Pharma / Bio Pharma

Development of a therapeutically active new entity as well as its dosage form(s) is a very challenging task for a Pharmaceutical product development .  Not only do they need to undertake toxicology profiling for their product, but also identify and characterize the impurities and storage driven degradants.They need to be critically examined for their genotoxic potential and possibly beyond, to save the product from re-assessments.

Impurity/degradant Profiling

• Impurity concentration/purification, characterization
• Generation of GLP Certificates of analysis for usage as authenticated reference samples for further work.
• Method development and validation for the actives, metabolites and degradants in diversified matrices

Mammalian toxicology evaluations

• MTD/Dose escalation with pharmacokinetics
• Dose range finding
• Sub acute/subchronic studies
• Genotoxicity evaluations
• Reproductive toxicity screening and Segment tests

All the above studies are performed in full compliance with ICH, EMA, FDA, WHO, and regional regulations like Schedule Y (India), ANVISA (Brazil) etc.

We endeavor to develop tailor made protocols based on the unique properties of your molecules to satisfy any specific regulatory requirements. All the laboratories of JRF Global are fully compliant with OECD Good Laboratory Practice (GLP) accreditation.

The most critical criterion for the pre-clinical studies are study updates and time line compliance. Our scientific team and professional project department have expertise to minimize the time and also to accelerate the studies in order to save time. We also provide timely updates of the projects to the sponsors.

With an exceptional quality and timely delivery of reports at very competitive prices as compared to the western labs, JRF Global is the right choice as your preferred partner for your IND / NDA / ANDA registrations.