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Biocon  /  Businesses  /  Generics  /  Regulatory Affairs

REGULATORY AFFAIRS

Regulatory Affairs

Biocon’s robust Regulatory team is fully equipped to develop regulatory strategy and manage compliance, risks and dossier submissions across the globe. The team leverages the obtained regulatory approvals to penetrate new markets quickly and cost effectively.

The API team has 50+ APIs, 500+ DMFs or equivalent to their credit, which span the US, EU, Australia, Canada, Japan, China, S. Korea, Brazil, Russia, Mexico, GCC countries, and 300+ domestic and multi-national customers. Our Finished Products team has established a strong footprint in the US and EU having submitted over 10 products to these markets, and a pipeline that stands strong. Our focus now includes China, Brazil, and other global markets.

Our team of experienced formidable professionals coordinates with regulatory agencies such as USFDA, MHRA, EU Agencies like ANSM and German Authorities, TGA, COFEPRIS as well as handles audits.

Our team of experienced formidable professionals coordinates with regulatory agencies such as USFDA, MHRA, EU Agencies like ANSM and German Authorities, TGA, COFEPRIS as well as handles audits. They are also experienced in handling the technical nuances of oral dosage forms (immediate release, modified release) and parenteral dosage forms (solution, lyophilized), apart from providing valuable insights in the field of complex molecules like peptides. Our regulatory experts conform to local, regional and global requirements, and coordinate and work with third-party manufacturing sites for some of our products.

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