Regulatory CMC Support

Regulatory Chemistry, Manufacturing, and Control (Reg CMC) strategy is vital throughout drug development, from conception to commercialization. Neglecting Reg CMC strategy can lead to costly delays and unnecessary work, diminishing project value.

To ensure we guide you in success:.

• Clear Manufacturing Process Description: Providing a concise description of your drug candidate's manufacturing process and controls to mitigate health authority questions and prevent delays in clearance or approval.
• Strategic Planning: Carefully planning your strategy to avoid oversharing or overcommitting during early development, preventing complications that slow progress.
• Operational Guidance: Relying on our Reg CMC experts for operational activities like contractor selection, risk mitigation, and documentation preparation for regulatory filings.
• Documentation Drafting: Ensuring meticulous documentation preparation for filings, meeting regulatory requirements, and including forward-looking commitments.
• Submission Review: Experienced Reg CMC professionals review regulatory filing documents, providing recommendations to de-risk submissions.
• Business Decision Support: Informing critical decisions by conducting technical and regulatory gap assessments during due diligence processes for drug development asset acquisitions.