Regulatory requirements for drug substances
With a central focus on human safety, high quality standards for drug products are upheld worldwide through various drug agencies.
Drug companies across the world adhere to high standards in order to ensure the safety and efficacy of drug products. While stringent measures are upheld at a global scale, regulatory documentation procedures for the filing of information on APIs in the context of a registration dossier varies from country to country.
Pamela Ventura, Head of Regulatory Affairs, at Recipharm sheds light on how to navigate regulatory requirements for drug substances and explores the discrepancies between the European and US market.
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