We specialize in offering Regulatory Toxicology Services including innovating solutions for Pharmaceutical R&D. Read more....

We specialize in offering Regulatory Toxicology Services including innovating solutions for Pharmaceutical R&D

Drug Development Services Consists of:

•Custom Synthesis and Process R&D
•DMPK – in-vitro and in-vivo
•Regulatory Toxicology and Safety Pharmacology
•Clinical Pharmacology

Advantage:

•BA Support from Early Discovery to Clinical Trials
•Time Effective IND Enabling Studies – CMC and Pharm / Tox

Engagement Models:

•Fee for Service
•FTE Based

Regulatory Toxicology Offerings:

Largest and Most Accredited Center in the INDIAN Region

•NDA Enabling Studies
•IND Enabling Studies
•Regulatory Ecotoxicology Studies
•More than 5000 Regulatory Studies Submitted
•24 Complete IND Packages Successfully Submitted to Several Agencies

Accreditations:

• Bfr German Health Ministry
• W&V the Netherlands ( Since 1999)
• AAALAC ( Since 2001 )
• Indian GLP Authorities ( Since 2005 )
• USFDA ( Since 2012 & First successful GMP Inspection in India with NO 483s )

Safety Assessment – Toxicology and Safety Pharmacology

• Histopathology
• ADVIA

Track Record of Approval of Complete Packages:

• USFDA -9
• Health Canada-6
• EMA-5
• MHRA, UK -1
• HSA, Singapore- 1
• Medsafe, New Zealand-1
• DCGI, India- 1

NDA Enabling Studies:

Pharmaceuticals:
• Chronic Toxicology Studies
• Reprotox Studies
    o Male Fertility Studies (Seg I)
    o Teratology Studies (Seg II)
    o Generation Studies (Seg III)
• Carcinogenicity Studies
• Transgenic Mice Studies
• Juvenile Toxicity Studies

For more details on Infrastructure, Carcinogenicity Studies,Animals Available,Team’s Expertise, Corporate Quality Assurance, Test Item Store & Dispensary, Project Management & IT Systems, Electronic Data Processing & Historical Data Bank, Archiving Facility & Examples of Protocols, Routes of Administration, Study Designs, please email us on udeetjbanker@manusakttevabiopharma.in
Why Us
Your product search made swift, simplified & successful in experienced hands. Test us to get the best of us Active Pharmaceutical Ingredients & Intermediates. New Molecule R&D, Scale up & Commercialization Technical Data package, CMC data package & Drug master files for most of the products as a part of our service Our partnerships are market-driven and are aimed at delivering real business value to our clients To Strive harder & excel further for the sevice of mankind by offering our services to the industry

Global Sourcing

Goto Top