Eurofins Advinus
Eurofins Advinus: your CDMO partner for all your CMC and nonclinical development requirements. We offer Exploratory Toxicology, CMC, Safety Pharmacology and Regulatory Toxicology as an end to end package
Eurofins Advinus is part of Eurofins CDMO and is based in India. We are your leading partner for specialized preclinical services for a complete IND/IMPD package that includes Safety Assessment/Toxicology and Drug Metabolism and Pharmacokinetic (DMPK) studies along with Chemistry, Manufacturing and Controls (CMC) services.
Our chemistry services include process chemistry, analytical chemistry and also custom synthesis of advanced intermediates & building blocks ranging from milligram to multi kilogram scale. We have state-of-the-art cGMP facility to generate up to multi kilo batches of NCEs to support Phase I & Phase II clinical trials.
We offer the full range of safety assessment studies required for all phases of nonclinical development, including exploratory toxicology, IND-directed toxicology and long-term toxicology studies directed towards NDA filing. Over the years our data has been successfully submitted by sponsors to regulatory agencies around the world – USFDA, EMA, MHRA, HSA etc. We have a track record of developing over 60 INDs for global regulatory submission by sponsors.
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Chemistry Services |
| cGMP synthesis of drug substance |
Process development, optimization and scale-up |
Custom synthesis |
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API and intermediates |
NCEs and NCE intermediates |
Custome chemical synthesis |
| Process improvement |
Hazard operability analysis (HAZOP) |
Analytical chemistry |
| Pre-formulation R&D |
Method development and validation |
Method verification and transfer |
| Impurity isolation, identification and profiling |
Forced degradation and stability testing |
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Pre-clinical Services |
| DMPK |
Safety pharmacology |
Genotoxicity |
| Safety assessment |
Bioanalytical support |
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Choose Eurofins Advinus to help you:
✔ Develop gram to multi-gram scale synthesis
✔ Establish robust and economical routes for the synthesis of NCEs / APIs
✔ cGMP scale-up for early development
✔ Isolation, synthesis and characterization of process related impurities
✔ Analytical Method Development
✔ Develop regulatory-compliant analytical services to support Chemistry, Manufacturing & Control (CMC) campaigns
✔ Complete Exploratory and regulatory IND enabling toxicology studies
✔ Impurity qualification toxicology studies
✔ Get your drug candidate approved by global regulatory agencies
