About Common Research and Technology Development Hub (CRTDH)

Funded jointly by the Department of Scientific and Industrial Research (DSIR), Government of India and the Council of Scientific and Industrial Research (CSIR) with the main objective of providing assistance to MSME and Startups.

• ➤ Cutting-edge formulations for global regulatory filing
• ➤ Super-generics, branded generics and ethical generics
• ➤ Pilot-scale QbD process development and scale-up
• ➤ Complete Product Monograph, GLP testing for stability/batch release
• ➤ Pharmacokinetics, Bioavailability, Bioequivalence
• ➤ “Flexi-fit” pilot-scale GMP-compliant manufacturing facility
• ➤ Regulatory Compliance and Certification
• ➤ GMP-compliant Production Capacity and Capability

About the Workshop

Drug manufacturers, contract research and manufacturing organizations (CROs/CMOs) and regulatory service providers (consultants), especially Micro-, Small- and Medium-Scale Enterprises (MSME), students (especially of Medicine and Pharmaceutical Sciences),and academic researchers are invited to this event with biomedical researchers, physicians and drug regulatory personnel from the CDSCO and UPFSDA.

The formal programme of this event will comprise two Open Forums: Regulatory, Medical and Academic. A panel of domain experts will make short presentations over the initial 30 minutes. Members of the audience will approach the Session Moderator with questions addressed to the Regulatory Authorities. The moderator will anonymize the query on request, moderate, collate and compile questions during the next 30 minutes.