BRS can provide regulatory affairs and drug development services across the entire life cycle. We have worked successfully with small biotechnology companies and large multi-national companies. We are able to work remotely or on‑site as an integral part of your team. Services offered include:
- Specialist in regulatory affairs requirements for the European Union; including new chemical entities, biological therapies, and generics.
- Experienced in US, Australian and New Zealand regulatory systems.
- Highly experienced in Regulatory Agency meetings, including the preparation of briefing packages. Practical experience with the FDA, EMEA, TGA, MHRA and various other European agencies, across all stages of the pharmaceutical life cycle.
- Preparation of regulatory documentation, including:
US Investigational New Drug applications (IND), EU Clinical Trial Authorisation applications (CTA), Australian Clinical Trial Exemption (CTX) and New Zealand SCOTT applications.
Investigational Medicinal Product Dossiers (IMPD) and Investigators’ brochures (IB)
Orphan drug applications
Drug master files (DMF), Modules 1, 2 and 3 of the Common Technical Document (CTD) and compilation of the complete dossier.
Bibliographical and mixed basis (bibliographical and original studies) dossiers
- Regulatory support throughout the license application process.
- Preparation of drug development tools, including development plans, MS Project plans, and Target Product Profiles.
- Project management of your drug development program.
- Due diligence activities
- BRS has a close working relationship with regulatory affairs professionals in the EU and US. What we don’t know we can easily find out.