Regulatory Affairs (RA)

Our regulatory experts understand the challenges faced by the biotech and pharmaceutical industry in navigating the complex landscape of regulatory requirements. Our team of seasoned regulatory affairs professionals is skilled in assisting you and your team at every step of your regulatory journey, from pre-IND to post-marketing activities. With our deep understanding of how to fulfill the regulatory requirements while mitigating risk, and experience in various therapeutic areas including rare diseases, we can help you streamline the development and approval processes.

We provide Regulatory Affairs services in:

• Regulatory Affairs Development and Strategic Advisory Support (IND/IMPD/NDA/BLA/MAA support and advice)
• Regulatory Health Authorities meeting support and drafting
• Regulatory Dossier Review
• Regulatory CMC (Phase 1-3, NDA/BLA/MAA drafting)