Overview
Chemistry, Manufacturing, and Controls (CMC) is the foundation of your drug product—and one of the most common sources of FDA delays. Our CMC strategy services ensure that your manufacturing processes, analytical methods, and quality systems are designed to meet FDA expectations from the earliest development stages. We help you avoid the costly surprises that come from CMC gaps discovered late in development or during agency review.
Key Features
Our Process
CMC Assessment
We evaluate your current manufacturing processes, analytical methods, and documentation against FDA requirements.
Strategy Development
We create a CMC roadmap that aligns with your clinical and commercial timelines.
Implementation Support
We work with your CMC teams and CDMOs to execute the strategy, reviewing protocols and data as they're generated.
Submission Readiness
We prepare your Module 3 documentation to tell a compelling quality story to regulators.
Frequently Asked Questions
Relevant Regulatory Guidance
Why Choose Us
- Avoid Refuse to File letters due to CMC deficiencies
- Reduce manufacturing changes during late-stage development
- Build a defensible control strategy from the start
- Prepare for FDA and global regulatory CMC requirements
- Streamline technology transfer and scale-up
Get More Details
Request a personalized consultation and detailed information about this service.
We'll respond within 24 hours
Ready to get started?
Contact our team to discuss your specific needs for CMC & Manufacturing Strategy.
Schedule ConsultationWhat Our Clients Say
"Our CDMO was great at manufacturing but didn't fully understand FDA expectations for the NDA. Adelphi bridged that gap, reviewing our CMC package and identifying issues that would have caused an RTF. Their CMC expertise was critical to our approval."
Dr. Robert Kim
VP of CMC
Pharma Company
Related Services
Explore other ways we can support your regulatory needs
Preclinical Strategy
Expert guidance on preclinical study design, toxicology requirements, and IND-enabling studies.
Clinical Development Oversight
Strategic oversight of Phase I-IV clinical trials, including protocol development and regulatory milestone management.
Program Management
End-to-end program management from IND through NDA/BLA, coordinating cross-functional teams.