End-to-end regulatory support for a gene therapy MAA submission

Boyds was engaged by a US-based biotechnology company to provide regulatory consultancy services for the preparation and submission of a Marketing Authorisation Application (MAA) for a novel gene therapy in the European Medicines Agency (EMA) region.

Comprehensive regulatory support for a gene therapy BLA submission

Boyds was engaged by a Finnish biopharmaceutical company to provide regulatory consultancy services for the preparation and submission of a Biologics License Application (BLA) for an innovative gene therapy.