Specializing in MENA Regulation, EU MDR 2017/745, Biosimilars, FDA submissions, and ISO 13485 compliance.

As a Freelance Regulatory and Business Consultant, I support clients across biosimilars, sterile generics, and medical device categories. My services span from gap analysis, technical documentation, CTD/eCTD submissions, and CE marking to training on global regulatory frameworks and regulatory-business alignment. I also contribute to commercial strategy by evaluating market entry strategies, managing audits, and identifying growth opportunities in emerging markets.