Aphex Pharma Solutions offers a range of CMC advisory and CMC management 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
- CMC Project Management
- Method Development
- Drug Substance Development
- Drug Product Development
- Stability Planning and Program Management
- Technology Transfer
- Designing Phase Appropriate API and Drug Product Specifications
- CMC Gap Analysis and Roadmap
- Process Validation
- Process Risk Assessment and (QbD) implementation
- Injectable, Nasal, Solids, Liquid, Semisolid, and Powder Dosage Forms
- Small Molecule, Large Molecule and Biologics
- CMC Budget Management and Tracking
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.
Why Aphex?
Why invest in expensive internal resources for CMC and quality management when Aphex Pharma Solutions offers a cost-effective, expert-driven alternative? Building and maintaining an in-house CMC and Quality team requires significant time, capital, and ongoing training to keep up with evolving regulatory standards. At Aphex, we bring decades of combined experience in CMC management, advisory and strategy, and quality management, ready to plug into your operations immediately. From early development through to commercial manufacturing, we serve as your dedicated CMC and quality management team, providing scalable support, industry-aligned best practices, and a commitment to excellence without the overhead.
With a strong foundation in scientific expertise and a commitment to operational excellence, Aphex Pharma Solutions' collaborative culture, focus on quality, and client-first mindset make us a trusted partner.
Contact us at info@aphexpharma.com to book an appointment or if you have any enquiries.