Regulatory experts understand the challenges faced by the biotech and pharmaceutical companies in navigating the challenges and changes of regulatory requirements. Our team of seasoned regulatory affairs professionals is skilled in assisting early phase and late stage companies with the step of regulatory journey, from pre-IND to post-marketing activities. Fulfill the regulatory requirements while mitigating risk, and experience in various therapeutic areas including rare diseases, we can help streamline the development and approval processes.

Regulatory Affair Services Includes

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