Formulation, Process & Device Department

• Setup and development of analytical methods • Analytical support to formulation and process studies • QC testing of batches involved in in-vivo studies and supervision of bioanalysis • QC Testing of GMP batches • Microbiology (monitoring of GMP Pilot Plant) • Non-G...

• Supervision of IBs, protocols and related documents • Initiation and follow-up of clinical trials • Selection and contact of CROs

• Manufacturing of pilot /scale-up batches • Manufacturing of GMP and clinical batches • Preparation of clinical kits

• Overall QA system • Internal and external audits

• Supervision of GMP activities • Release of GMP and clinical batches • Relationship with agencies • Consolidation and maintenance of regulatory documents