|
Bioequivalence
Certified Internacional Bioequivalence Centers
Argentina
| DIFFUCAP - EURAND S.A.C.I.F.I. |
| CERTIFICATION: Resolução
RE n° 4.749, de 17 de dezembro de 2008 |
| HISTORY |
| RESPONSIBLES |
| COORDINATOR OF THE CENTER: Silvia
Susana Giarcovich
QUALITY ASSURANCE MANAGER: Silvia Susana
Giarcovich
RESPONSIBLE FOR THE CLINICAL PHASE: Andres
Spatz
RESPONSIBLE FOR THE STATISTICAL PHASE: Silvia
Susana Giarcovich |
| BIOEQUIVALENCE HEADQUARTER |
| Adress: Ingeniero Torcuato Di Tella, 968, Piñeyro Avellaneda – Argentina
- CEP: B1868BIB
Phone/Fax: 54 11
4208 2975/2815 / 54 11 4208 2275
E-mail: research@diffucap.com e silvia.giarcovich@diffucap.com |
| CLINICAL PHASE
Total number of beds: 24 |
| CLINICAL UNIT FACILITY:
Hospital Alemán
Adress:
Av. Pueyrredon N. 1640, Norte, Capital
Federal, Buenos
Aires - CEP: C118AAT
Phone/Fax: 54 11
4827 7000 / 54 11 4827 7014
E-mail: andresspatz@diffucap.com; rmastai@hospitalaleman.com |
| PATHOLOGY LAB: Laboratório Domecq
Y Lafage SA
Technical Responsible: -
Adress: Av. Pueyrredon N. 1640, Norte, Capital Federal, Buenos Aires - CEP: C118AAT
Phone/Fax: 54 11 4827 7000 / 54 11 4827 7014
E-mail: dirtec@labdyl.com.ar |
| STATISTICAL
PHASE |
| Adress: Ingeniero
Torcuato Di Tella,
968, Piñeyro, Avellaneda – Argentina
- CEP: B1868BIB
Phone/Fax: 54 11
4208 2975/2815 / 54 11 4208 2275
E-mail: silvia.giarcovich@diffucap.com |
Australia
|
Q-PHARM PTY Limited
|
|
CERTIFICAÇÃO: Resolução – RE nº 1.021
de 20 de março de 2009
|
|
HISTORY
|
|
RESPONSIBLES
|
|
COORDINATOR
OF THE CENTER: Terence Gordon Hurst
QUALITY ASSURANCE MANAGER: -
RESPONSIBLE FOR THE CLINICAL PHASE: Joanne
Marjason
RESPONSIBLE FOR THE ANALYTICAL PHASE: -
RESPONSIBLE FOR THE STATISTICAL PHASE: Peter
O’Rourke
|
|
BIOEQUIVALENCE HEADQUARTER
|
|
Adress: 300 Herston Road, Brisbane, Queensland – Austrália – CEP:
4006
Phone/Fax: 61 7 3845 3636 / 61 7 3845 3637
E-mail: t.hurst@qpharm.com.au
|
|
CLINICAL PHASE
Total number of beds: 48
|
|
CLINICAL
UNIT FACILITY: Q-PHARM PTY Limited
Endereço: : 300 Herston Road, Brisbane, Queensland – Austrália – CEP:
4006
Phone/Fax: 61 7 3845 3636 / 61 7 3845
3630
E-mail: j.marjason@qpharm.com.au
|
|
PATHOLOGY LAB: Sullivan & Nicolaides Pathology
Responsável
Técnico: Dr. Tony Badrick
Adress: 134 Whitmore St., Taringa, Brisbane, Queensland – Austrália
- 4068
Phone/Fax:61
7 3377 8782 / 61 7 3377 8686
E-mail: courtney_butler@snp.com.au
|
|
STATISTICAL
PHASE
|
|
Adress: 300 Herston Road, Brisbane, Queensland – Austrália – CEP:
4006
Phone/Fax: 61 7 3845 3579 / 61 7 3845 3503
E-mail: peter.orourke@qimr.edu.au
|
|
TETRAQ Quality Preclinical Solutions
|
|
CERTIFICATION: Resolution
RE nº 1759, de 08 de maio de 2009
|
|
HISTÓRICO
|
|
RESPONSIBLES
|
|
COORDINATOR OF
THE CENTER: Russell Addison
QUALITY ASSURANCE
MANAGER -
RESPONSIBLE FOR
THE ANALYTICAL PHASE: Russell Addison
|
|
BIOEQUIVALENCE HEADQUARTER
|
|
Adress: Block 6, Royal Brisbane & Womens Hospital,
via Q-Pharm, Brisbane, Queensland, Austrália - 4029
Phone/Fax: 61 7 3365 5115 / 61 7 3365 5444
E-mail: r.addison@uq.edu.au
|
|
ANALYTICAL PHASE
|
|
Adress: Block 6, Royal Brisbane & Womens Hospital, via Q-Pharm, Brisbane, Queensland, Austrália -
4029
Phone/Fax: 61 7 3365 5115 / 61 7 3365 5444
E-mail: r.addison@uq.edu.au
|
Canadá
|
Algorithme
Pharma Inc
|
|
CERTIFICATION: Resolução
RE nº 1.023, de 20 de março de
2009
|
|
HISTORY
|
|
RESPONSIBLES
|
| COORDINATOR
OF THE CENTER: Mr. Louis
Caille
QUALITY ASSURANCE MANAGER: -
RESPONSIBLE FOR THE CLINICAL
PHASE: Claude Tremblay
RESPONSIBLE FOR THE ANALYTICAL
PHASE: Dr. Fabio Garofolo
RESPONSIBLE FOR THE STATISTICAL
PHASE: Dr. Marc Lefebvre
|
|
BIOEQUIVALENCE HEADQUARTER
|
|
Adress: 575 Armand-Frappier Blvd. Laval, Quebec – Canadá. CEP:
H7V 4B3
Phone/Fax: 450 973 6077
/ 450 973 1412
E-mail: ymoras@algopharm.com
|
|
CLINICAL PHASE
Total number of beds: 224
|
|
CLINICAL
UNIT FACILITY: Algorithme
Pharma Inc
Adress: 1200 Beaumont
Avenue. Mount-Royal, Quebec – Canadá. CEP: H3P 3P1
Phone/Fax: 514 858 6077 / 514
858 5260
E-mail: ctremblay@algopharm.com
|
|
CLINICAL
UNIT FACILITY: Gamma
Dynacare
Technical Responsible: Lyse
Marshall
Adress: 175
Stillview Road, Suíte 155, Pointe-Claire.
Quebec – Canadá. CEP: H3R
4S3
Phone/Fax: 514 697 3831
/ 514 697 7938
E-mail: marshalll@gamma-dynacare.com
|
|
ANALYTICAL PHASE
|
|
Adress: 575 Armand-Frappier Blvd. Laval, Quebec – Canadá. CEP:
H7V 4B3
Phone/Fax: 450
973 6077 / 450 973 1412
E-mail: fgarofolo@algopharm.com
|
|
STATISTICAL
PHASE
|
|
Adress: 575 Armand-Frappier Blvd. Laval, Quebec – Canadá. CEP:
H7V 4B3
Phone/Fax: 450
973 6077 / 450 973 1412
E-mail: mlefebvre@algopharm.com
|
| Anapharm Inc. |
| CERTIFICATION:
RE nº 4.675, de 16 de outubro de 2009 |
| HISTORY |
| RESPONSIBLES |
| COORDINATOR OF THE CENTER: Johane Boucher-Champagne
QUALITY ASSURANCE MANAGER: Serge St-Laurent
RESPONSIBLE FOR THE CLINICAL PHASE: Peter Ross
RESPONSIBLE
FOR THE ANALYTICAL PHASE:
Robert Massé
RESPONSIBLE FOR THE STATISTICAL PHASE: Mario Tanguay |
| BIOEQUIVALENCE HEADQUARTER |
| Adress:
Einsten Street, 2500, Québec - Canadá - CEP:
G1P0A2
Phone/Fax: 418 527 4000 / 527 3456
E-mail: sstlaurent@anapharm.com |
| CLINICAL PHASE
Total number of beds: 674
|
| CLINICAL
UNIT FACILITY:Seleção
e Recrutamento (Anapharm Inc.)
Adress: 5190,
boul. Des Forges. Trois-Riviéres – Quebec,
Canadá. G8Y 1X3.
Phone/Fax: 819
375-0343 / 819 375-9529
E-mail: pross@anapharm.com |
| CLINICAL
UNIT FACILITY:
Anapharm Inc
Adress:
Einstein Street, 2500. Quebec – Quebec, Canadá.
G1P 0A2.
Phone/Fax:
418 527-4000 / 418 527-3456
E-mail: pross@anapharm.com |
| CLINICAL
UNIT FACILITY:Anapharm
Inc
Adress:
5160
Décarie, 8th floor. Montreal – Quebec, Canadá.
H3X 2H9.
Phone/Fax:
514 485-7500 / 514 485-7501
E-mail: pross@anapharm.com |
CLINICAL
UNIT FACILITY: Anapharm
Inc.
Adress:
4101 Yonge Street – Suite 600, Toronto – Ontário
– Canadá – M2P 1N6
Phone/Fax: 416 227-1512 / 416 227-1502
E-mail: pross@anapharm.com |
| PATHOLOGY LAB: Anapharm
Inc.
Technical Responsible:
Adress: 5160
Décarie, 8th floor. Montreal – Quebec, Canadá.
H3X 2H9.
Phone/Fax: 514
485-7500 / 514 485-7501
E-mail: rmasse@anapharm.com |
| ANALYTICAL PHASE |
| Adress:
Einsten Street, 2500, Québec - Canadá - CEP:
G1P0A2
Phone/Fax: 418 527 4000 / 418 527 3456
E-mail: rmasse@anapharm.com |
| STATISTICAL
PHASE |
| Adress:
Einsten Street, 2500, Québec - Canadá - CEP:
G1P0A2
Phone/Fax: 418
527 4000 / 418 527 3456
E-mail: mtanguay@anapharm.com |
Índia
| Accutest Research Laboratories (I)
Pvt Ltd |
| CERTIFICATION:
RE nº 4.798,
de 23 de outubro de 2009 |
| HISTORY |
| RESPONSIBLES |
| COORDINATOR OF THE CENTER:
Nirav Gandhi
QUALITY
ASSURANCE MANAGER: Paresh Mistry
RESPONSIBLE
FOR THE CLINICAL PHASE: Nirav Gandhi
RESPONSIBLE FOR THE ANALYTICAL PHASE:
Arvind Jangid
RESPONSIBLE FOR THE STATISTICAL PHASE:
Kunal Paliwal |
| BIOEQUIVALENCE HEADQUARTER |
| Endereço:
Opp The Grand Bhagwati Hotel, Sarkhej Gandhinagar
Highway, Bodakdev Ahmedabad - Índia - CEP: 380015
Phone/Fax:
91 79 2676-7353 / 2676-7356
E-mail: nirav@accutestindia.com |
| CLINICAL PHASE
Total
number of beds: - |
| CLINICAL UNIT
FACILITY I: Accutest Research Laboratories
(I) PVT. LTD.
Adress: The Grand Monarch, 4th floor,
Near Seema Hall, Anad Nagar Road, Satellite, Ahmedabad
- Índia - CEP: 380015
Phone/Fax:
91 79 2676-7353 / 2676-7355
E-mail: nirav@accutestindia.com |
| CLINICAL UNIT FACILITY
II: Accutest Research Laboratories (I) PVT. LTD.
Adress: Opp The Grand Bhagwati
Hotel, Sarkhej Gandhinagar Highway, Bodakdev Ahmedabad
- Índia - CEP: 380015
Phone/Fax:
91 79 2676-7353 / 2676-7355
E-mail: nirav@accutestindia.com |
| PATHOLOGY LAB
: - Accutest Research laboratories (I) PVT.LTD
Technical Responsible:
Nitin Makvana
Adress: Opp The Grand Bhagwati Hotel,
Sarkhej Gandhinagar Highway, Bodakdev Ahmedabad - Índia
- CEP: 380015
Phone/Fax: 91
79 2676-7353 / 2676-7355
E-mail: nirav@accutestindia.com |
| ANALYTICAL PHASE |
| Adress: Opp The Grand Bhagwati Hotel,
Sarkhej Gandhinagar Highway, Bodakdev Ahmedabad - Índia
- CEP: 380015
Phone/Fax:
91 79 2676-7353 / 2676-7355
E-mail: arvind@accutestindia.com |
| STATISTICAL
PHASE |
| Adress:Opp The Grand Bhagwati Hotel,
Sarkhej Gandhinagar Highway, Bodakdev Ahmedabad - Índia
- CEP: 380015
Phone/Fax:
91 79 2676-7353 / 2676-7355
E-mail: kunal@accutestindia.com |
|
Axis
Clinical Ltd.
|
|
CERTIFICATION: Resolução
-RE nº 4.745 de 19 de dezembro
de 2008
|
|
HISTORY
|
|
RESPONSIBLES
|
|
COORDINATOR OF THE CENTER: Dr. Jayachandra Reddy
QUALITY ASSURANCE MANAGER: M. Sathish
RESPONSIBLE FOR THE CLINICAL PHASE: Dr. Jayachandra Reddy
RESPONSIBLE FOR THE ANALYTICAL PHASE: Mr. Phanibhusana Reddy
RESPONSIBLE FOR THE STATISTICAL PHASE:S. Shehar
|
|
BIOEQUIVALENCE HEADQUARTER
|
|
Adress:Sy. No. 66 (part) & Sy.
No. 67 (part), Miyapur,
Serilingampally, Hyderabad, Andhra Pradesh - Índia
Phone/Fax: 91 40 40408080/ 91 40
40408003
E-mail: tr sarath@tridentlife.com
|
|
CLINICAL PHASE
Total number of beds: 162
|
|
CLINICAL UNIT FACILITY: Axis Clinical Ltd.
Adress: Sy. No. 66 (part) & Sy.
No. 67 (part), Miyapur, Serilingampally, Hyderabad,
Andhra Pradesh - Índia
Phone/Fax:91 40 40408080/ 91 40
40408003
E-mail: jcreddy@tridentlife.com
|
|
PATHOLOGY LAB: Axis Clinical Ltd.
Technical Responsible:Dr. Ch. Srinivasa Rao
Adress: Sy. No. 66 (part) & Sy.
No. 67 (part), Miyapur, Serilingampally, Hyderabad,
Andhra Pradesh - Índia
Phone/Fax: 91 40 40408080/ 91 40
40408003
E-mail: jcreddy@tridentlife.com
|
|
ANALYTICAL PHASE
|
|
Adress:Sy. No. 66 (part) & Sy.
No. 67 (part), Miyapur, Serilingampally, Hyderabad,
Andhra Pradesh - Índia
Phone/Fax:91 40 40408080/ 91 40
40408003
E-mail:pbreddy@tridentlife.com
|
|
STATISTICAL
PHASE
|
|
Adress: Sy. No. 66 (part) & Sy.
No. 67 (part), Miyapur, Serilingampally, Hyderabad,
Andhra Pradesh - Índia
Phone/Fax: 91 40 40408080/ 91 40
40408003
E-mail: shekar@tridentlife.com
|
| Bombay Bioresearch Center (BBRC) |
| CERTIFICATION: RE
nº 4.556, de 09 de outubro de 2009 |
| HISTORY |
| RESPONSIBLES |
| COORDINATOR OF THE CENTER: Dharmedra Ved
QUALITY ASSURANCE MANAGER: -
RESPONSIBLE FOR THE CLINICAL PHASE: Dr Roysuneel V.
Patankar
RESPONSIBLE FOR THE ANALYTICAL PHASE: Dr.Shrikant
H. Rane
RESPONSIBLE FOR THE STATISTICAL PHASE: Anup
P. Parab |
| BIOEQUIVALENCE HEADQUARTER |
| Adress: Plot
nº35, Ancillary Ind Plots, Govandi, Mumbai, Índia
- CEP 400 043
Phone/Fax: (91) 22 2551 / 1212/
2520 / 2121
E-mail: bbrc@rediffmail.com
|
| CLINICAL PHASE
Total number of beds: 72 |
| CLINICAL UNIT FACILITY:
Bombay
Bioresearch Center (BBRC)
Adress: Plot
nº35, Ancillary Ind Plots, Govandi, Mumbai, Índia
– CEP: 400 043
Phone/Fax: (91) 22 2551 / 1212/
2520 / 2121
E-mail:
bbrc@rediffmail.com |
| PATHOLOGY LAB: Clinical Diagnostic
Centre
Technical Responsible:
Adress: A-2, Ben Nevis,
Ground Floor, Bhudabhai Desaid Road, Mumbai, Índia
– CP 400036
Phone/Fax: (91) 22 23684764 /
23671019
E-mail: cdcindia@vsnl.com |
|
PATHOLOGY LAB: Samant Pathology Laboratory
(PROCESS OF CERTIFICATION)
Adress: 113, 126, Laxmi Market, Above Ratnakar Bank,
Vartak Nagar Naka. Thane (West), Maharashtra. CEP 400
606.
Phone/Fax:
E-mail: -
|
| ANALYTICAL PHASE |
| Adress: Plot
nº35, Ancillary Ind Plots, Govandi, Mumbai, Índia
CEP 400 093
Phone/Fax: (91) 22 2551 / 1212/ 2520 / 2121
E-mail: sonusingh@zyduscadila.com |
| STATISTICAL
PHASE |
| Adress: CPlot
nº 29 a 33 e 35, Ancillary Ind Plots, Govandi,
Mumbai, Índia CEP 400 093
Phone/Fax: (91) 22 2551 1212/ 2520 2121
E-mail:
bbrc@rediffmail.com |
|
Clinsys
Clinical Research Ltd
|
|
CERTIFICATION: RE nº 3.450,
de 14 de agosto de 2009
|
|
HISTORY
|
|
RESPONSIBLES
|
|
COORDINATOR OF THE CENTER: Ashish
Jain
QUALITY
ASSURANCE MANAGER: Sachin Satija
RESPONSIBLE
FOR THE CLINICAL PHASE: Jogesh
Mahajan
RESPONSIBLE FOR THE ANALYTICAL PHASE: Monika
Bhakri
RESPONSIBLE FOR THE STATISTICAL PHASE: Kamlesh
Patel
|
|
BIOEQUIVALENCE HEADQUARTER
|
|
Adress:
C-46, Sector-62, Gautam Buddh Nagar, Noida, Uttar
Pradesh, Índia - CEP 201 307
Phone/Fax: (91) 120 4364000 / (91) 120 2404336
E-mail: ashish_jain@clinsys.com
|
|
CLINICAL PHASE
Total number of beds: 62
|
|
CLINICAL UNIT FACILITY:
Clinsys Clinical Research ltd
Adress:
C-46, Sector-62, Gautam Buddh Nagar, Noida, Uttar
Pradesh, Índia
- CEP 201 307
Phone/Fax: (91) 120 4364000 / (91) 120 2404336
E-mail: jogesh_mahajan@clinsys.com
|
|
PATHOLOGY LAB: Clinsys Clinical Research ltd
Technical Responsible: Sunita Upadhyaya
Adress:
C-46, Sector-62, Gautam Buddh Nagar, Noida, Uttar Pradesh, Índia
- CEP 201 307
Phone/Fax: (91) 120 4364000 / (91) 120 2404336
E-mail: sunita_upadhyaya@clinsys.com
|
|
ANALYTICAL PHASE
|
|
Adress: C-46, Sector-62,
Gautam Buddh Nagar, Noida, Uttar Pradesh, Índia
- CEP 201 307
Phone/Fax: (91) 120 4364000 / (91) 120 2404336
E-mail: monika_bhakri@clinsys.com
|
|
STATISTICAL
PHASE
|
|
Adress: C-46, Sector-62,
Gautam Buddh Nagar, Noida, Uttar Pradesh, Índia
- CEP 201 307
Phone/Fax: (91) 120 4364000 / (91) 120 2404336
E-mail: kamlesh_patel@clinsys.com
|
| Fortis
Clinical Research Limited |
| CERTIFICATION: RE nº 4.420, de 02 de outubro de
2009 |
| HISTORY |
| RESPONSIBLES |
| COORDINATOR OF THE CENTER: Dr. Ashok Rattan
QUALITY ASSURANCE MANAGER: Meenakshi Bakshi
RESPONSIBLE FOR THE CLINICAL PHASE: Dr. Deepak Chilkoti
RESPONSIBLE FOR THE ANALYTICAL PHASE: Ms.
Shireen Rao
RESPONSIBLE FOR THE STATISTICAL PHASE: Mr.
Shekar Sunkoju |
| BIOEQUIVALENCE HEADQUARTER |
| Adress: Sunflag
Hospital & Research Centre Sector 16A – Faridabad
– Haryana– Índia – CEP: 121002
Phone/Fax: 91 0129-4090900 / 91 0129-4090924
E-mail: ashok.rattan@fortis-cro.com |
| CLINICAL PHASE
Total number of beds: 78 |
| CLINICAL UNIT FACILITY:
Fortis
Clinical Research Limited
Adress:
C/o Sunflag Hospital & Research
Centre Sector 16A – Faridabad – Haryana – Índia – CEP:
121002
Phone/Fax: 91 0129-4090900 / 91 0129-4090924
E-mail: deepak.chilkoti@fortis-cro.com |
| PATHOLOGY LAB:
Clinical Laboratory, Ranbaxy Clinical
Pharmacology & Development
Technical
Responsible:Sonaile Kalra
Adress: GP-5,
Sector 18, Old Delhi, Gurgaon – Índia –
CEP: 122001
Phone/Fax: 91 124-4768000 / 124-47688199
E-mail: sonalie.kalra@ranbaxy.com |
| PATHOLOGY LAB:
SRL Ranbaxy Limited, Regional Reference
Laboratory
Technical
Responsible:
Dr. Aparna Ahuja
Adress:
GP-26,
Maruti Industrial Estate, Udyog Vihar, Sec-18, Phase-4,
Gurgaon - Haryana - Índia – CEP: 122022
Phone/Fax: 91 124-4591000 / 124-4591001
E-mail: aparna.ahuja@sri.in |
| ANALYTICAL PHASE |
| Adress: C/o Sunflag Hospital & Research
Centre Sector 16A – Faridabad – Haryana – Índia – CEP:
121002
Phone/Fax :91 0129-4090900 / 91 0129-4090924
E-mail: shireen.rao@fortis-cro.com |
| STATISTICAL
PHASE |
| Adress: C/o Sunflag Hospital & Research
Centre Sector 16A – Faridabad – Haryana – Índia – CEP:
121002
Phone/Fax: 91 0129-4090900 / 91 0129-4090924
E-mail:
shekar.sunkoju@fortis-cro.com |
| Glenmark
Generics Research Center |
|
CERTIFICATION:Resolução
RE nº 1155, de 2de abril de 2009
|
| HISTORY |
| RESPONSIBLES |
| COORDINATOR OF THE CENTER: Dr. Mubeen A. Khan
QUALITY ASSURANCE MANAGER: Sra.
Madhu Solomon
RESPONSIBLE FOR THE CLINICAL PHASE: Dr.
Nikhil Sawant
RESPONSIBLE FOR THE ANALYTICAL PHASE: Dr. Rajesh
karwa
RESPONSIBLE FOR THE STATISTICAL PHASE: Sr. Ramakrishna Battula |
| BIOEQUIVALENCE HEADQUARTER |
| Adress: B/2,
Mahalaxmi Chambers,
22, Bhulabhai Desai
Road, Mahalaxmi, Mumbai, Maharashtra – Índia -
CEP: 400 026
Phone/Fax: 91 22 4018 9999
/ 91 22 4118 9986
E-mail: mubeen@glenmark-generics.com |
| CLINICAL PHASE
Total number of beds: 72 |
| CLINICAL UNIT FACILITY:
Glenmark
Research Center
Adress:
Plot Nº D-508, T.T.C., Industrial
Area, Turbhe-Thane,
Navi Mumbai,
Maharashtra – Índia - CEP: 400705
Phone/Fax: 91 22 2761 1721 / 1722 / 91 22 2768
0321
E-mail: snikhil@glenmark-generics.com |
| PATHOLOGY LAB: Glenmark
Research Center
Technical Responsible:
Dr.
U. M. Vaidya
Adress: Clinical
Pathology Laboratory, Clinical Research Unit, Plot nº
D-508, T.T.C., Industrial Area, Turbhe-Thane, Navi Mumbai,
Maharashtra – Índia - CEP: 400613
Phone/Fax: 91 22 2761 1721 / 91 22 2768 0321
E-mail: snikhil@glenmark-generics.com |
| ANALYTICAL PHASE |
| Adress: Plot Nº A-607, T.T.C. Industrial
Area, MIDC, Mahape,
Thane, Navi
Mumbai, Maharashtra – Índia -
CEP: 400 709
Phone/Fax:91 22 6513 2491 / 6772 0000 / 91 22
2778 2525
E-mail: rajesh@glenmark-generics.com |
| STATISTICAL
PHASE |
| Adress:Plot Nº A-607, T.T.C. Industrial
Area, MIDC, Mahape,
Thane, Navi
Mumbai, Maharashtra – Índia -
CEP: 400 709
Phone/Fax: 22 5654 9999 / 2351481 / 22 2351 9652
E-mail: rajesh@glenmark-generics.com |
| GVK BIOSCIENCES
PVT LTD |
| CERTIFICATION:
RE nº 4.533, de 08 de outubro
de 2009 |
| HISTORY |
| RESPONSIBLES |
| COORDINATOR OF THE CENTER: Dr Sailendra Kumar
Goswami
QUALITY ASSURANCE MANAGER:
Dr. Ravi Sankar
RESPONSIBLE FOR THE CLINICAL PHASE: Dr Naba Kumar Talukdar
RESPONSIBLE FOR THE ANALYTICAL PHASE: Chandra Sekhar Vadla
RESPONSIBLE FOR THE STATISTICAL PHASE: Mr. Raveendranath Gaddam |
| BIOEQUIVALENCE HEADQUARTER |
| Adress: 7th floor, Swarna Jayanthi Commercial
Complex, Ameerpet, Hyderabad, Andhra Pradesh - CEP: 500 038
Phone/Fax: 91
40 6627-5555 / +91 40 6627-5599
E-mail:
sailendra.goswami@gvkbio.com
|
| CLINICAL PHASE
Total number of beds: 144 |
| CLINICAL UNIT FACILITY:
GVK
Biosciences PVT. LTD
Adress:
7th floor, Swarna Jayanthi Commercial Complex, Ameerpet,
Hyderabad, Andhra Pradesh - CEP: 500 038
Phone/Fax: 91
40 6627-5555 / +91 40 6627-5599
E-mail: naba.talukdar@gvkbio.com
|
| PATHOLOGY LAB: Elbit Medical Diagnostics Limited
Technical Responsible:
Mr. B. Nageshwara Rao
Adress: AG.
Heights, 8-2-703, Road nº 12, Banjara Hills, Hyderabad
- Andrha Pradesh - CEP: 500 034
Phone/Fax: 91
40 23372731 / 91 40 23372740
E-mail: elbit@rediffmail.com |
| PATHOLOGY
LAB: GVK Biosciences Private Limited
(IN PROCESS OF CERTIFICATION)
Technical Responsible: Mr. K. Suryanarayana Kommu
Adress: 7th floor, Swarna Jayanthi
Commercial Complex, Ameerpet, Hyderabad, Andhra Pradesh
- CEP: 500 038
Phone/Fax: 91 40 6627-5555 / +91 40
6627-5599
E-mail: suryanarayana.kommu@gvkbio.com |
| ANALYTICAL PHASE |
| Adress:
7th floor, Swarna Jayanthi Commercial Complex, Ameerpet,
Hyderabad, Andhra Pradesh - CEP:
500 038
Phone/Fax: 91
40 6627-5555 / +91 40 6627-5599
E-mail: csekhar.vadla@gvkbio.com |
| STATISTICAL
PHASE |
| Adress: 7th
floor, Swarna Jayanthi Commercial Complex, Ameerpet,
Hyderabad, Andhra Pradesh - CEP:
500 038
Phone/Fax: 91
40 5562 8888 / 91 40 5562 2655
E-mail:
raveendranath.gaddam@gvkbio.com |
LAMBDA
THERAPEUTIC RESEARCH PVT. LTD.
|
|
CERTIFICATION: Resolução – RE
nº 4.747 de 19 de dezembro de 2008
|
|
HISTORY
|
|
RESPONSÁVEIS
|
|
COORDINATOR OF THE CENTER: V. Srivatsan
QUALITY
ASSURANCE MANAGER: Sunil Budhkar
RESPONSIBLE
FOR THE CLINICAL PHASE: Dr. Charu Gautam
RESPONSIBLE FOR THE ANALYTICAL PHASE: Prashant Kale
RESPONSIBLE FOR THE STATISTICAL PHASE: Ms.
Ruchy Shah
|
|
SEDE DO CENTRO DE BIOEQUIVALÊNCIA
|
|
Adress: Plot n° 38, Near Silver OaK Club, S.G. Highway, Gota, Gujarat ,
Ahmedabad – India -
CEP: 380 061
Phone: 9179 40202020
Fax: 9179 40202021
E-mail: vsrivatsan@lambda-cro.com
|
|
CLINICAL PHASE
Total number of beds: 248 (Ahmedabad)
100 (Chennai e 40 (Mumbai)
|
|
CLINICAL UNIT FACILITY: Lambda Therapeutic Research Limited
Adress: Plot n° 38, Near Silver OaK Club, S.G. Highway, Gota, Gujarat ,
Ahmedabad – India -
CEP: 380 061
Phone/Fax: 9179 40202020/ 9179 40202021
E-mail: charu@lambda-cro.com
|
|
CLINICAL UNIT FACILITY: Lambda
Therapeutic Research Limited
Adress: 25A, Silkasia, N.P. Industrial Estate, Ground Floor, Ekkaduthangal,
Chennai, Tamilnadu – Índia - CEP: 600
097
Phone/Fax: 9144 22252726/
22252716/ 22252715 / (22252431)
E-mail: vsrivatsan@lambda-cro.com / mjoseph@lambda-cro.com
|
|
CLINICAL UNIT FACILITY: Lambda
Therapeutic Research Limited
Adress: 701, The Great Eastern Summit – A, Plot n° 56,
Sector 15, CBD, Belapur - India -
CEP: 400 614
Phonel/Fax: 9122 27562220/
27562224/ 27564118 / (27562231)
E-mail: vsrivatsan@lambda-cro.com / deepaksawhney@lambda-cro.com
|
|
PATHOLOGY
LAB:
Lambda
Therapeutic Research Limited
Responsável Técnico: Mukesh Agrawal
Adress: Plot n° 38, Near Silver OaK Club, S.G. Highway, Gota, Gujarat ,
Ahmedabad – India -
CEP: 380 061
Phone/Fax: 9179 40202020/
9179 40202021
E-mail: vsrivatsan@lambda-cro.com / mukeshagrawal@lambda-cro.com
|
|
ANALYTICAL PHASE
|
|
Adress: Plot n° 38, Near Silver OaK Club, S.G. Highway, Gota, Gujarat ,
Ahmedabad – India -
CEP: 380 061
Phone/Fax: 9179 40202020/
9179 40202021
E-mail: prashant@lambda-cro.com
|
|
STATISTICAL
PHASE
|
Adress: Plot n° 38, Near Silver OaK Club, S.G. Highway, Gota, Gujarat ,
Ahmedabad – India -
CEP: 380 061
Phone/Fax: 9179 40202020/
9179 40202021
E-mail: ruchyshah@lambda-cro.com
|
| Lotus Labs Pvt. Ltd. |
| CERTIFICATION: RE nº 4.164,
de 22 de setembro de 2009 |
| HISTORY |
| RESPONSIBLES |
| COORDINATOR OF THE CENTER: Dr. Saral Thangam
QUALITY ASSURANCE MANAGER: Mr. Krishnamurthy Rao C.A.
RESPONSIBLE FOR THE CLINICAL PHASE: Dr. Sandhya Ravi
RESPONSIBLE FOR THE ANALYTICAL PHASE: Mrs. Radha Shekar
RESPONSIBLE FOR THE STATISTICAL PHASE: Mr. Mani Kandasamy |
| BIOEQUIVALENCE HEADQUARTER |
| Adress: # 7, Jasma Bhavan Road, Millers Tank
Bed Area, Vasanth Nagar, Bangalore Mahanagarapalike,
Bangalore – Índia - CEP: 560 052
Phone/Fax: 91 80 22370912 /13 /14 /15 / 91 80
22370911
E-mail: sudhirpai@lotuslabs.com e saralt@lotuslabs.com |
| CLINICAL PHASE
Total number of beds: - |
| CLINICAL UNIT FACILITY:
Lotus
Labs PVT Ltd
Adress:
#
141/2 St. Johns Nagar, Oppt. BDA Complex, 100 ft Road,
3rd Block, Koramangala,
Bangalore – Índia - CEP: 560 034
Phone/Fax: 91 80 2563 0714 / 91 80 2563 0799
E-mail: shoba_rajagopal@lotuslabs.com e james@lotuslabs.com |
| CLINICAL UNIT FACILITY:Lotus
Labs PVT Ltd
Adress:
#
7, Jasma Bhavan Road, Millers Tank Bed Area, Vasanth
Nagar, Bangalore –
Índia - CEP: 560 052
Phone/Fax:
044 2847 5962 / 044 2847 2060
E-mail: shoba_rajagopal@lotuslabs.com e kavitha_muniraj@lotuslabs.com |
| CLINICAL UNIT FACILITY:Lotus
Labs PVT Ltd
Adress:
# 56 (old # 116), Dr. Radhakrishnan Salai, Mylapore,
Chennai – Índia - CEP: 600 004
Phone/Fax:
91 80 22370912 /13 /14 /15 / 91 80 22370911
E-mail:shoba_rajagopal@lotuslabs.com e kala_s@lotuslabs.com |
|
CLINICAL UNIT FACILITY:
Lotus Labs Pvt. Ltd
Endereço: # 02, M. M. Towers, Jakkur Plantation, Yalahanka Hobli,
Bangalore – India – CEP 560064 Tel/Fax: 9180 28567263/ 91 80
28567270
E-mail: shoba_rajagopal@lotuslabs.com e rajeev.s@lotuslabs.com
|
| PATHOLOGY LAB: Lotus Labs Pvt
Technical Responsible:
Dr.
Anuradha Srikrishna
Adress: #
7, Jasma Bhavan Road, Millers Tank Bed Area, Vasanth
Nagar, Bangalore –
Índia - CEP: 560 052
Phone/Fax: 91 80 22370912 /13 /14 /15 / 91
80 22370911
E-mail: anuradha.k@lotuslabs.com |
| ANALYTICAL PHASE |
| Adress:
# 7, Jasma Bhavan Road, Millers Tank Bed Area, Vasanth
Nagar, Bangalore – Índia
- CEP: 560 052
Phone/Fax: 91
40 5562 8888 / 91 40 5562 2655
E-mail: radhashekar@lotuslabs.com |
| STATISTICAL
PHASE |
| Adress: # 7, Jasma Bhavan Road, Millers Tank Bed Area, Vasanth
Nagar, , Bangalore – Índia
- CEP: 560 052
Phone/Fax:91 80 22370912 /13 /14 /15 / 91
80 22370911
E-mail:
mani@lotuslabs.com |
|
Macleods
Pharmaceuticals Limited
|
|
CERTIFICATION:
RE nº 4.268, de 25 de setembro de
2009
|
|
HISTORY
|
|
RESPONSIBLES
|
|
COORDINATOR
OF THE CENTER: Ashish Mungantiwarl
QUALITY ASSURANCE MANAGER: Sagar Pawar
RESPONSIBLE FOR THE CLINICAL PHASE: Vijay Kumar
RESPONSIBLE FOR THE ANALYTICAL PHASE: Dr. Mandar R.
Mote
RESPONSIBLE FOR THE STATISTICAL PHASE: Mr. Pankaj Bhangale
|
|
BIOEQUIVALENCE HEADQUARTER
|
|
Adress: G-2, Mahakali
Caves Road, Andheri (East), Mumbai - India – CEP:
400 093
Phone/Fax: 022 2830 6435 / 2831 4611 / 2830 4641
E-mail: drashish@macleodspharma.com
|
|
CLINICAL PHASE
Total number of beds: 40
|
|
CLINICAL UNIT FACILITY: Macleods
Pharmaceuticals Limited
Adress: G-2,
Mahakali Caves Road, Andheri (East),
Mumbai - India – CEP: 400 093
Phone/Fax: 022 2830
6435 / 2831 4611 / 2830 4641
E-mail: drashish@macleodspharma.com
|
|
PATHOLOGY LAB: Macleods
Pharmaceuticals Limited
Technical Responsible: Akil
Kazi Khan
Adress: G-2,
Mahakali Caves Road, Andheri (East),
Mumbai - India – CEP: 400 093
Phone/Fax: 022 2830
6435 / 2831 4611 / 2830 4641
E-mail: drashish@macleodspharma.com
|
|
ANALYTICAL PHASE
|
|
Adress: G-2,
Mahakali Caves Road, Andheri (East), Mumbai - India – CEP:
400 093
Phone/Fax: 022 2830 6435
/ 2831 4611 / 2830 4641
E-mail: drashish@macleodspharma.com
|
|
STATISTICAL
PHASE
|
|
Adress: G-2,
Mahakali Caves Road, Andheri (East), Mumbai - India – CEP:
400 093
Phone/Fax: 022 2830 6435
/ 2831 4611 / 2830 4641
E-mail: drashish@macleodspharma.com
|
| Ranbaxy
Research Laboratories |
| CERTIFICATION: RE nº 4.087,
de 18 de setembro de 2009 |
| HISTORY |
| RESPONSIBLES |
| COORDINATOR OF THE CENTER: Dr. Tausif Monif
QUALITY ASSURANCE MANAGER: Dra. Simrit Reyar / Dr. Shri Prakash
Singh
RESPONSIBLE FOR THE CLINICAL PHASE: Dr. Nilanjan Saha
RESPONSIBLE FOR THE ANALYTICAL PHASE:
Arshad
Khuroo
RESPONSIBLE FOR THE STATISTICAL PHASE:
Vikesh
Srivastav |
| BIOEQUIVALENCE HEADQUARTER |
| Adress: Plot no GP5, HSIDC, Sector 18, Old Delhi-Gurgaon
Road, Gurgaon Haryana - India
Phone/Fax: 91
124 4231001/ 91 124 4231002
E-mail: tausif.monif@ranbaxy.com |
| CLINICAL PHASE
Total number of beds: 83 |
| CLINICAL UNIT FACILITY:
Fortis Hospital Complex
Adress: B-22, Sector –
62, Noida, Uttar Pradesh, India
Phone/Fax:
91-120- 2404-09397/ 91-120-2403989
E-mail:
monika.tandon@ranbaxy.com |
| PATHOLOGY LAB:
Ranbaxy Clinical Pharmacology Unit
Technical
Responsible:
Dr.
Sonalie Kalra
Adress: Plot no GP5, HSIDC, Sector
18, Old Delhi-Gurgaon Road, Gurgaon Haryana - India
Phone/Fax:
91-1244768000-47688199/91 124 4231002
E-mail:
sonalie.kalra@ranbaxy.com |
| PATHOLOGY LAB:
Super Religare Laboratories
Technical
Responsible:
Dr.
Ashok Rattan.
Adress: GP-26,
Maruti Industrial State, Udhyog Vihar, Sec-18, Phase-4,
Gurgaon, Haryana – India
E-mail:
ashok.rattan@srlranbaxy.co.in |
| ANALYTICAL PHASE |
| Adress: Plot no GP5, HSIDC, Sector 18, Old Delhi-Gurgaon
Road, Gurgaon Haryana - India
Phone/Fax:
91 124 4231001/ 91 124
4231002
E-mail: arshad.khuroo@ranbaxy.com |
| STATISTICAL
PHASE |
| Adress: Plot no GP5, HSIDC, Sector 18, Old Delhi-Gurgaon
Road, Gurgaon Haryana - India
Phone/Fax:
91 124 4231001/ 91 124
4231002
E-mail:
vikeshk.shrivastav@ranbaxy.com
|
| RELIANCE
LIFE SCIENCES |
| CERTIFICATION: Resolução -
RE nº 1.417, de 24 de abril de
2009 |
| HISTORY |
| RESPONSIBLES |
| COORDINATOR OF THE CENTER:
Dr Suresh Maroli
QUALITY ASSURANCE MANAGER: Durka Phalke
RESPONSIBLE FOR THE CLINICAL PHASE: Dr. Somnath Banerjee , Dr. Prashant
Pandya e Dr. Devi Manjula
RESPONSIBLE FOR THE ANALYTICAL PHASE: Aslam Khan
RESPONSIBLE FOR THE STATISTICAL PHASE: Yogesh
Sable |
| BIOEQUIVALENCE HEADQUARTER |
| Adress:
Dhirubhai
Ambani Life Science Centre, Thane Belapur Road, Navi
Mumbai, Índia
CEP: 400701
Phone/Fax: 91 22 67678201 / +91 22 67678299
E-mail: sunil.chaudhry@relclin.com |
| CLINICAL PHASE
Total number of beds:
88 (Navi Mumbai) / 59 (Bangalore) |
| CLINICAL UNIT FACILITY:
Reliance
Clinical Pharmacology and Pharmacokinetic Facility
Adress: Dhirubhai
Ambani Life Science Centre, Thane Belapur Road, Navi
Mumbai, Índia. CEP: 400701
Phone/Fax: +91
22 67678000 / +91 22 67678299
E-mail: somnath_banerjee@relbio.com
/ prashant_pandya@relbio.com
|
| CLINICAL
UNIT FACILITY: RelClin
– Reliance Clinical Research Services Pvt Ltd,
Bangalore
Adress:
nº 65-373-2, 1st phase, 2 nd, BTM layout, Bangalore,
Karnataka, Índia. – CEP: 560 076
Phone/Fax:
91
80 6626-1323/ +91 80 6626-1340
E-mail: devi_manjula@relbio.com |
| PATHOLOGY LAB: Pathology, reliance
Clinical Pharmacology and Pharmacokinetic Facility
Technical Responsible:
Dr. Preeti Kabra
Adress: Dhirubhai Ambani
Life Science Centre, Thane Belapur Road, Navi Mumbai,
Índia. – CEP:
400701
Phone/Fax:
+91 22 67678000 / +91 22 67678299
E-mail: preeti.kabra@relclin.com |
PATHOLOGY
LAB: Lotus Labs Pvt
Technical Responsible: Dr. Anuradha Srikrishna
Adress: # 7, Jasma Bhavan Road, Millers Tank Bed Area, Vasanth Nagar, Bangalore
Mahanagarapalike, Índia - CEP: 560 052
Phone/Fax: 91 80 22370912 /13 /14 /15 / 91 80 22370911
E-mail: anuradha.k@lotuslabs.com |
| ANALYTICAL PHASE |
| Adress: Dhirubhai
Ambani Life Science Centre, Thane Belapur Road, Navi
Mumbai, Índia – CEP: 400701
Phone/Fax:
+91 22 67678000 / +91 22 67678299
E-mail: aslam_khan@relbio.com |
| STATISTICAL
PHASE |
| Adress: Dhirubhai
Ambani Life Science Centre, Thane Belapur Road, Navi
Mumbai, Índia – CEP: 400701
Phone/Fax:
+91 22 67678000 / +91 22 67678299
E-mail: yogesh.sable@relclin.com |
| SUN
Pharmaceutical Industries LTD |
| CERTIFICATION:
RE nº 4.829, de 29 de outubro de 2009 |
| HISTORY |
| RESPONSIBLES |
| COORDINATOR OF THE CENTER:Thennati
Rajamarnnar
QUALITY ASSURANCE MANAGER: -
RESPONSIBLE FOR THE CLINICAL PHASE: Khanna
Aman Romesh
RESPONSIBLE FOR THE ANALYTICAL PHASE: Neel
Kamal Mohan
RESPONSIBLE FOR THE STATISTICAL PHASE: Biren
PandyaBiren Pandya |
| BIOEQUIVALENCE HEADQUARTER |
| Adress: Tandalja,
Baroda, Vadodara - Índia
Phone/Fax: (91) 265 235 0756 / 265235
4897
E-mail: trajamannar@sunpharma.com
|
| CLINICAL PHASE
Total number of beds: - |
| CLINICAL UNIT FACILITY:
Sun
Pharmaceutical Industries Ltd
Adress: Tandalja,
Baroda, Vadodara - Índia
Phone/Fax: (91) 265 235 0756 / 265235
4897
E-mail: aman.khanna@sunpharma.com |
| PATHOLOGY LAB: Sun Pharmaceutical Industries Ltd
Technical Responsible:
JNileshkumar Shankarlal Pantel
Adress: Tandalja,
Baroda, Vadodara - Índia - CEP 390 020
Phone/Fax:(91) 265 235 0756 / 265235
4897
E-mail: nileshpantel@sunpharma.com |
| ANALYTICAL PHASE |
| Adress: Tandalja,
Baroda, Vadodara - Índia - CEP 390 020
Phone/Fax: (91) 265 235 0756 / 265235
4897
E-mail: neel.k.mohan@sunpharma.com |
| STATISTICAL
PHASE |
| Adress: Tandalja,
Baroda, Vadodara - Índia - CEP 390 020
Phone/Fax: (91) 265 235 0756 / 265235
4897
E-mail:
birenpandia@sunpharma.com |
| Torrent
Pharmaceutical Ltd |
| CERTIFICATION: Resolution
- RE n° 1.881, de 21 de maio de 2009 |
| HISTORY |
| RESPONSIBLES |
| COORDINATOR OF THE CENTER: Ambrish Kumar Srivastava
QUALITY ASSURANCE MANAGER: S. K. Vyas
RESPONSIBLE FOR THE CLINICAL PHASE: Tejas
Talati
RESPONSIBLE FOR THE ANALYTICAL PHASE: Jignesh Bhatt
RESPONSIBLE FOR THE STATISTICAL PHASE: Vaishali Thakker |
| BIOEQUIVALENCE HEADQUARTER |
| Adress: Village Bhat, Gandhinagar,
Ahmedabad, Gujarat, Índia - CEP 382428
Phone/Fax: 91 079 23969100 / 23969124
/ 91 079 23969135
E-mail:ambrishsrivastava@torrentpharma.com |
| CLINICAL PHASE
Total number of beds: 30 |
| CLINICAL UNIT FACILITY:
Torrent Reseach Centre
Adress: Village
Bhat, Gandhinagar, Ahmedabad, Gujarat, Índia
- CEP 382428
Phone/Fax: 91
079 23969100 / 23969124 / 91 079 23969135
E-mail: trcpku@torrentpharma.com |
| PATHOLOGY LAB: Pre-Clinical Safety Evaluation - PCSE
Technical Responsible:
Dra. Mamta Soni
Adress: Village Bhat, Gandhinagar, Ahmedabad, Gujarat, Índia
- CEP 382428
Phone/Fax: 91 079 23969100 / 23969124 / 91 079 23969135
E-mail:trcpku@torrentpharma.com |
| ANALYTICAL PHASE |
| Adress: Village Bhat, Gandhinagar, Ahmedabad,
Gujarat, Índia - CEP 382428
Phone/Fax: 91 079 23969100
/ 23969124 / 91 079 23969135
E-mail:gsubbaiah@torrentpharma.com |
| STATISTICAL
PHASE |
| Adress: Village Bhat, Gandhinagar, Ahmedabad, Gujarat, Índia
- CEP 382428
Phone/Fax: 91 079 23969100 / 23969124 / 91 079 23969135
E-mail:
trcpku@torrentpharma.com |
| Veeda Clinical Research Pvt. Ltd. |
| CERTIFICATION: RE nº 4.966, de 06 de novembro de 2009 |
| HISTORY |
| RESPONSIBLES |
| COORDINATOR OF THE CENTER: SRajendra Prasad M.
QUALITY ASSURANCE MANAGER:Chakrapani Majumba
RESPONSIBLE FOR THE CLINICAL PHASE: Sanjay
Sharma
RESPONSIBLE FOR THE ANALYTICAL PHASE: Manish Yadav
RESPONSIBLE FOR THE STATISTICAL PHASE: Nikunj
Bhalt |
| BIOEQUIVALENCE HEADQUARTER |
| Adress: Shivalik-Plaza-A,
Near I.I.M, Ambawadi, Gujarat, Ahmedabad – Índia – CEP:
380 015
Serilingampally, Hyderabad, Andhra Pradesh - Índia
Phone/Fax: 079 3001 3000
/ 079 3001 3010
E-mail: - rajendra.prasad@veedacr.com |
| CLINICAL PHASE
Total number of beds: 109 |
| CLINICAL UNIT FACILITY:
Veeda
Clinical Research Pvt. Ltd.
Adress: Shivalik-Plaza-A,
Near I.I.M, Ambawadi, Gujarat, Ahmedabad – Índia – CEP:
380 015
Phone/Fax: 079 3001 3000 /
079 3001 3010
E-mail: sanjay.sharma@veedacr.com |
| PATHOLOGY LAB: Supratech Micropath
Lab Research Institute
Technical Responsible: Dr. Sandip Shah
Adress: "Kedar”,
Near parimal Garden – Ahmedabad, Gujarat – Índia – CEP:
380006
Phone/Fax: 079 26408181/
079 26409292
E-mail:supratech1@yahoo.com
|
| ANALYTICAL PHASE |
| Adress:
Shivalik-Plaza-A, Near I.I.M, Ambawadi, Gujarat, Ahmedabad
– Índia – CEP: 380 015
Phone/Fax:
079 3001 3000 / 079 3001 3010
E-mail: manish.yadav@veedacr.com |
| STATISTICAL
PHASE |
| Adress: Shivalik-Plaza-A,
Near I.I.M, Ambawadi, Gujarat, Ahmedabad – Índia – CEP:
380 015
Phone/Fax: 079 3001 3000 / 079 3001 3010
E-mail: nikinj.bhatt@veedacr.com |
|
Zydus
Research Centre
|
|
CERTIFICATION: Resolução
- RE nº 2.674, de 2 de julho de
2009
|
|
HISTORY
|
|
RESPONSIBLES
|
|
COORDINATOR
OF THE CENTER: Dr. Rajendra H. Jani
QUALITY ASSURANCE MANAGER: Dr. Tanuja Kulshrestha
RESPONSIBLE FOR THE CLINICAL PHASE: Dr. Alpesh Patel
RESPONSIBLE FOR THE ANALYTICAL PHASE: Sr. Harilal Patel
RESPONSIBLE FOR THE STATISTICAL PHASE: Sra. Ansuya
Verma
|
|
BIOEQUIVALENCE HEADQUARTER
|
|
Adress:
Sarkhej-Bavla National Highway n°8A, Moraiya, Ahmedabad,
Gujarat - Índia - CEP: 382 213
Phone/Fax: 91 79 2717-250801 / 2717-250606
E-mail: tanujakulshrestha@zyduscadila.com
|
| CLINICAL PHASE
Total number of beds: 52
|
|
CLINICAL UNIT FACILITY: Zydus Research
Centre
Adress: Sarkhej-Bavia National Highway nº 8A,
Moraiya, Ahmedabad, Gujarat, India - CEP: 382 213
Phone/Fax: 91 79 2717-250801
E-mail: rhjani@zyduscadila.com
|
|
PATHOLOGY LAB: Zydus Research Centre
/ Clinical Chemistry
Technical Responsible: Vijay Kale
Adress: Sarkhej-Bavia National Highway nº 8A,
Moraiya, Ahmedabad, Gujarat, India - CEP: 382 213
Phone/Fax: 91 79 2717-250801
E-mail: mukuljain@zyduscadila.com
|
|
ANALYTICAL PHASE
|
|
Adress: Sarkhej-Bavia
National Highway nº 8A, Moraiya, Ahmedabad,
Gujarat, India - CEP: 382 213
Phone/Fax:91 79 2717-250801
E-mail: rhjani@zyduscadila.com
|
|
STATISTICAL
PHASE
|
|
Adress:Sarkhej-Bavia
National Highway nº 8A, Moraiya, Ahmedabad,
Gujarat, India - CEP: 382 213
Phone/Fax:91 79 2717-250801
E-mail: rhjani@zyduscadila.com
|
Itália
| Mader S.R.L. |
| CERTIFICATION: Resolution RE nº 3.366, de 07 de agosto de 2009 |
| HISTORY |
| RESPONSIBLES |
| COORDINATOR OF THE CENTER: Guido Vandoni
QUALITY ASSURANCE MANAGER: Marino Gobetti
RESPONSIBLE FOR THE STATISTICAL PHASE: Cláudio
Montoro |
| BIOEQUIVALENCE HEADQUARTER |
| Adress: Viale Certosa, 269, Milano, Lombardia - Itália
Phone/Fax: 0039 02 38001384 / 0039 02 38003292
E-mail: info@on-mader.com |
| STATISTICAL PHASE |
| Adress: Viale Certosa,
269, Milano, Lombardia - Itália
Phone/Fax: 0039
02 38001384 / 0039 02 38003292
E-mail: info@on-mader.com |
| R&D
LABS. |
| CERTIFICATION: Resolution
- RE nº 247, de 28 de janeiro de 2009 |
| HISTORY |
| RESPONSIBLES |
| COORDINATOR OF THE CENTER: Sergio Pengo
QUALITY ASSURANCE MANAGER: Roberto
Orlandi
RESPONSIBLE FOR THE ANALYTICAL PHASE: Ivana Ramazzotti |
| BIOEQUIVALENCE HEADQUARTER |
| Adress: Via G.
Ferrari, nº 21, Saronno,
Varese, Lombardia - Itália
Phone/Fax: 0039
02 96700802 / 0039 02 96701176
E-mail: info@rdlabs.eu |
| ANALYTICAL PHASE |
| Adress: Via G. Ferrari,
Nº 21 – Scala D
Phone/Fax: 0039 02 96700802 / 0039 02 96701176
E-mail: info@rdlabs.eu |
Northern
Ireland
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MDS
Pharma Services GB Limited
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CERTIFICATION: Resolução
RE nº 3.836, de 02 de setembro de 2009
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HISTORY
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RESPONSIBLES
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COORDINATOR
OF THE CENTER: Fiona Mc Neily
QUALITY ASSURANCE MANAGER: Doxy Fragiskatos (Belfast) and Eliane Schaefer
(Lincoln)
RESPONSIBLE FOR THE CLINICAL PHASE: Fiona Mc Neily
RESPONSIBLE FOR THE ANALYTICAL PHASE: Chad Briscoe
RESPONSIBLE FOR THE STATISTICAL PHASE: Anthea Cromie and Michelle L.
Combs
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BIOEQUIVALENCE HEADQUARTER
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Adress:
22-24 Lisburn Road, Belfast, Northern Ireland, Reino
Unido, CEP BT9 6AD
Phone/Fax: 028 9055-4040 / 028 9055-4141
E-mail: fiona.mcneilly@mdsinc.com
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CLINICAL PHASE
Total number of beds: 78
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CLINICAL UNIT FACILITY:
MDS Pharma Services GB Limited
Adress: 22-24 Lisburn Road, Belfast, Northern Ireland,
Reino Unido, CEP BT9 6AD
Phone/Fax: 028 9055-4040 / 028 9055-4141
E-mail: fiona.mcneilly@mdsinc.com
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PATHOLOGY LAB: MDS Pharma
Services GB Limited
Technical Responsible: Conor Mc Kee
Adress: 22-24 Lisburn Road, Belfast, Northern Ireland,
Reino Unido, CEP BT9 6AD
Phone/Fax: 028 9055-4040 / 028 9055-4141
E-mail: conor.mckee@mdsinc.com
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ANALYTICAL PHASE
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Adress: 621 Rose Street,
Lincoln, Nebraska, Estados Unidos, CEP 68502
Phone/Fax: 402 476-2811 / 402 476-7598
E-mail: chad.briscoe@mdsinc.com
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STATISTICAL
PHASE
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Adress: 621 Rose Street,
Lincoln, Nebraska, Estados Unidos, CEP 68502
Phone/Fax: 402 476-2811 / 402 476-7598
E-mail: michelle.combs@mdsinc.com
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Adress: 22-24 Lisburn
Road, Belfast, Northern Ireland, Reino Unido, CEP BT9
6AD
Phone/Fax: 028 9055-4040 / 028 9055-4141
E-mail: anthea.cromie@mdsinc.com
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LEK
PHARMACEUTICALS D.D
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CERTIFICATION: RE
nº 4.797, de 23 de outubro de 2009
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HISTORY
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RESPONSIBLES
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COORDINATOR OF THE CENTER: Janja Luksa
QUALITY
ASSURANCE MANAGER: -
RESPONSIBLE FOR THE ANALYTICAL PHASE: Janja Luksa and
Darja Grabnar e Kristina Filipin
Primic
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BIOEQUIVALENCE HEADQUARTER
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Adress:Verovskova 57, Ljubljana. Estado 386. Eslovênia. CEP: 1526
Phone/Fax: 01
5802111/ 01 5681393
E-mail: janja.luksa@sandoz.com
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ANALYTICAL PHASE
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Adress: Verovskova 57, Ljubljana. Estado 386. Eslovênia. CEP: 1526
Phone/Fax: 01
5802111/ 01 5681393
E-mail: janja.luksa@sandoz.com; kristina.filipin_primic@sandoz.com
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Bioanalytical
Systems Inc (BASI)
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CERTIFICATION: Resolution
RE nº 1.882, de 21 de maio
de 2009
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RESPONSIBLES
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COORDINATOR OF THE CENTER: Kathleen Hodges
QUALITY
ASSURANCE MANAGER: -
RESPONSIBLE FOR THE ANALYTICAL PHASE: Kathleen Hodges
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BIOEQUIVALENCE HEADQUARTER
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Adress: 2701 Kent Ave. West Lafayette, Indiana – EUA. CEP: 47906
Phone/Fax: 765 497 5877
/ 765 497 8415
E-mail: khodges@bioanalytical.com
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ANALYTICAL PHASE
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Adress: 2701 Kent Ave. West Lafayette, Indiana – EUA. CEP: 47906
Phone/Fax: 765 497 5877
/ 765 497 8415
E-mail: khodges@bioanalytical.com
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