Sadhana Infotech Institute of Regulatory Affairs

The Diploma Program at Sadhana Infotech covers all aspects of professional requirements to be a successful regulatory expert.
Classes will be taught by 12+ Years of Industrial experienced professionals.
All life science graduates (M.Sc/B.pharm/M.pharm) and experienced individuals working in different domains (production QC, QA, AR&D, R&D etc..)
COURSE CONTENT:-
• Introduction about Pharma and Drug Regulatory Affairs
• ICH guidelines
• Practical Knowledge in Dossier/ANDA/DMF compilation
• Knowledge on reviewing CTD sections
• Regulatory Introduction and submission with USFDA (21CFR, 505(b)1, 505(b)2, GDUFA, Refuse to receive, QbD concept)
• Regulatory submission in Europe via Various procedures (DCP,MRP National and Centralized procedure)
• Post approval changes for both US and EU market (PAS,CB30,Annual Report, Type IA,Type IB and Type II variations)
• Handling of Regulatory quires efficiently and skill based training to troubleshoot the issues
• Mockup interview to gain the confidence