CMC

We offer a range of CMC advisory services to support the development of your products, from Pre-clinical to Phase III, taking into account FDA, EMA and other regulatory guidance. Our CMC advisory services include the following:

• Method Development
• Drug Substance Development
• Drug Product Development
• Stability Planning and Program Management
• CMC Project Management

CMC advisory: Our CMC experts can support all aspects of drug development and manufacturing, including identifying a suitable CDMO, formulation and process development, method development, designing phase-appropriate product specifications, and identifying required CMC studies before Clinical Trial Application (CTA) or New Drug Application (NDA). We also provide risk and change management advice for scale-up and technology transfer.

CMC project management: Many small organisations do not have the internal resources and expertise to manage their CMC program. We provide CMC project management services to ensure your CMC project progresses in line with the overall product development program by liaising with your CMO/CDMO on your behalf.