Amit Srivastava

Background

About Amit Srivastava

14 years of experience of working in Regulatory Affairs for regulated and semi-regulated countries - Europe, US, Australia, Brazil, ASEAN, CIS, African and Latin American countries. CTD/eCTD compilation- Module 3, Module 2 : Review, writing and compilation - Module 1, Module 4, Module 5: Compilation as per available raw data, CMC writing and review 2. ASEAN CTD (ACTD) Compilation- Part II (Quality, overall summary & Report): Review, writing and compilation - Part I and Part IV : Compilation as per available raw data. DMF review (CTD format): As per available raw data. Dossier compilation as per Individual Country requirement. e.g Russia, Ukraine, Kazakhstan, Malaysia, Myanmar, Philippines, Cambodia, Indonesia, Thailand, Vietnam, Ghana, Kenya, Nigeria, Tanzania, Guatemala, Australia, Dominican Republic and also for other semi regulated countries. Improving Regulatory Compliance : Technical Review of documents e.g Stability data, Process validation protocol and record, Analytical Method validation, Product development report, Certificate of analysis, Batch manufacturing record, Master formula etc. Assesment of dossier to identify deficiency, additions and omissions. Life Cycle management: Variations and post approval changes: Writing and compilations Renewals and Re-registration: Compilations Specialties: CMC- MODULE 3, CMC Technical Documents review