Dr. Hasumati Rahalkar, RAC (US, EU), FTOPRA

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Experienced professional with over 25 years of work experience in the Pharmaceutical Industry. in QA, QC, Regulatory Affairs and Product Development with core focus on handling regulatory affairs for US, EU and Emerging markets. She founded Metina PharmConsulting in 2012, focused on providing EU GMP & Global Regulatory services.
As a Regulatory Affairs lead in multinationals & currently as an Entrepreneur running a successful consulting service, she has spearheaded regulatory strategy development & execution for both small molecule generics & biosimilars. She gained strong expertise in defining Global Regulatory Strategies, Marketing Authorization Application submissions and approvals for New Drug Applications Branded generics & Biologics across Regulated & Emerging Markets.
She has also established GMP consulting as a core area of strength for the company with over 50 successful EU GMP certifications.
She is the first Indian regulatory professional to be awarded with TOPRA (The Organisation for Professionals in Regulatory Affairs, UK) Fellowship and has done her PhD in Regulatory Science with focus on Biosimilars, from the University of Hertfordshire- UK. She holds additional qualifications of Regulatory Affairs Certification (EU & US), Certification in Patent Drafting & Procedure, along with Post Graduate Diploma in Management & International Trade.