REGULATORY SERVICES
Our drug regulatory experts have a broad-based knowledge of the regulatory requirements for the different products and indications and know the local regulatory requirements around Europe inside out.
From early development, we provide regulatory advice throughout the entire life cycle of a medicinal product. We support contract partners in the provision of regulatory relevant documentation, ensure regulatory compliance for all products on the market and provide regulatory intelligence services.
Our specific expertise includes:
- Design of regulatory strategies, starting from the inception of a new product idea
- Prelimenary evaluation of dossiers content- Provision and assembly of complete registration dossiers for all newly developed and marketed products
- Assessment of existing regulatory files according to new target country national requirements- Submission and registration of dossiers at the selected national regulatory authorities
- Supporting marketing authorization procedure
- Consultancy and professional expertise in GMP, GLP, GCP areas