provider in India
in india
BIOREG is an adjuvant for all your need to speed up your drug registration and approval process. Our experience, professional relations understanding, practicality and familiarity in the field of regulation of Drugs and Pharmaceuticals, Medical Devices, IVDs, Biologicals (Vaccines, Cell and Cellular therapeutics, Blood products, DNA, Biosimilars) products serve to ease your way through the process. BIOREG, is all with you to receive expert advice, 24 hour support, practical guidance and complete technical assistance right from the development stage to the commercial launch to the import and marketing in the Indian market.
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).
The team at BIO REG is proficient in the subject matter and provide prompt services . We are satisfied with our engagement and would recommend their services.
We have been professionally associated with BIO REG from long time. Extensive knowledge of the regulations of the entire team is highly appreciable and marks the professionalism and quality driven ethics of the organization. All the best BIO REG. Keep going.
We have been associated with BIO REG for about a year now for our food products related services for FSSAI compliances and licenses from BIO REG and are completely satisfied with their performance. Quick turnaround time in responding to queries, meticulous planning in completing the task.We highly recommend their services as we believe it is best in the industry so far.
