ProRegulatory Biosciences

About ProRegulatory Biosciences

ProRegulatory Biosciences Ltd. is Canada’s federally incorporated pharmaceuticals and biotechnology regulatory affairs consulting company. We provide regulatory consulting and technical writing services by collaborating with various clients according to their requirements. We believe understanding Regulatory requirements correctly is the key to success in today’s global market. The ProRegulatory team has 15+ years of regulatory affairs experience in various regulated, semi-regulated, and rest of the world markets. The team contains a good pool of industry experts who have successfully received approvals at different development stages for Biologics/ANDAs in the US, Europe, and Canadian markets. The team has broad experience as described below but not least: • IND, Clinical Trial Applications, IMPD, MAA, BLA CTD Module 3 CMC regulatory writing and dossier preparation. • Biologics/biosimilar product development regulatory support for the US FDA, EMA, Health Canada, and other markets. • US FDA meeting/briefing packages and EMA scientific advice. • Product life cycle management for the US FDA, EMA, Canada, and the Rest of the World. • ANDA dossier preparation for the US FDA, EMA, Health Canada, and the Rest of the World. • Various regulatory applications for globally regulated markets.

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