Proflie: A Quality & Regulatory professional with 20+ years of CQA / QA / DQA (R&D_QA) / RA diversified experience in building Pharmaceutical / Bio-Pharmaceutical Quality Systems and Regulatory filings (DMFs / ANDAs / INDs / IMPDs / CTAs / MAAs / NDAs / BLAs) for Drug Substances, Drug Products & Combination Products (Drug Product + Medical Device) pertaining to the US & the EU markets with an end-to-end understanding from Pre-Clinical & Clinical stages to Commercialization & Post MKTG / Life Cycle Management stages in line with ICH Q7, ICH Q8, Q9, Q10, Q11, Q12 & Q13 & E6), ISO 13485 / CFR 820, 21 CFR Part 11 / EU Annex 11 & GAMP5 for APIs, Sterile & Non-Sterile formulations. including Biologics. My strong belief is to adopt an integrated approach with Quality Risk Management principles for Quality / Regulatory compliance and to simplify the QMS for the intended GxP (GLP, GCP, GMP, GDP) compliance through micro and macro level landscaping of the firm’s QMS. Types of audits conducted:Lead Auditor (GLP, GCP, GMP & GDP).Countries Covered: Open for any coutnry. traveled across EU, Japan, Malaysia, Taiwan and China apart from different locations in India as part of his audit assignments. Current City:Hyderabad. Language Expertise: English, Hindi