BEST REGULATORY AFFAIRS TRAINING INSTITUTES IN HYDERABAD IN HYDERABAD

Covalent is one of the leading training institutes for Regulatory Affairs in Hyderabad.Course Content of RA is Introduction to different types of Pharmaceutical products: Basic concepts on Rx, OTC, API, Starting material, DP/FP,Biologics vs. Biosimilars, Laws vs. Regulations vs. guidelines. Worldwide regulatory agencies and their role Approval process. Post-market regulatory obligations GLP’s: 21 CFR 58 -The History of GLP, The Idea behind GLP, The Areas of Application, The Pillars of Good Laboratory Practice,,Indian GLP and International GLP. CMC topics: GMP, Preformulation studies, ICH Q 7 guideline, 21 CFR 210 and 211, Medical device CE marking and ISO certifications.