Offering comprehensive regulatory solutions for biological products in India, ensuring compliance with CDSCO guidelines, clinical trial approvals, and post-market surveillance.
Complete lifecycle of the product. Leading regulatory services in India's pharmaceutical sector, guiding clients through CDSCO approvals, quality assessments, and post-authorization compliance.
Regulatory Guidance with our in-depth industry knowledge and strong track record.
Regulatory pathway development for the product.
Nutraceuticals product registration services.
Pathway for the Clinical development from Phase I to IV to help lifesaving treatments reach patients faster and thus leveraging the breadth of our clinical, regulatory, and therapeutic expertise.
Development of regulatory pathways for Drugs and Pharmaceuticals, Medical Devices, IVDs, Biologicals (Vaccines, Cell and Cellular therapeutics products, Gene therapeutic product, antisera ,Plasma derived products/Blood products, rDNA, Biosimilar, Cosmetics,)
Clinical trials services including the Global clinical trials, preclinical studies, Testing of samples at central Drug Laboratory(CDL), Central Drug Testing laboratory (CDTL labs), National Institute of Biologicals(NIB).