Late-Stage Services
Scaling, Optimizing, and Delivering for Clinical and Commercial Success
MedPharm’s Late-Stage Services are designed to guide drug products through the most critical phases of development: Phase II, Phase III, and preparation for commercial launch. As your product advances, the need for process robustness, regulatory compliance, and commercial scalability becomes paramount—and that’s where MedPharm excels.
We combine scientific rigor with real-world manufacturing and regulatory expertise to ensure late-stage programs are executed efficiently, with a clear path toward market readiness and sustained success.
Our Late-Stage Capabilities Include:
Process Development, QbD, and Scale-Up
- Advanced process optimization based on Design of Experiments (DoE) principles
- Technology transfer and scale-up for Phase II/III clinical manufacturing
- Process characterization to meet regulatory expectations
Clinical Trial Material Manufacturing
- GMP production of Phase II and III clinical supplies
- Batch record preparation, packaging, labeling, and global distribution
- Seamless collaboration with CROs and clinical partners
Analytical & Stability Services
- Validation of analytical methods to support regulatory filings
- ICH-compliant stability studies for late-phase and commercial submissions
- Ongoing batch release and quality testing
Registration Batches & Regulatory Submission Support
- Production of registration and validation batches (PPQ)
- Full CMC documentation support for NDA, ANDA, and MAA submissions
- Global regulatory expertise to guide successful approval
Why Choose MedPharm for Late-Stage Development?
- Proven success moving products from Phase II to commercialization
- GMP-compliant manufacturing, packaging, and quality testing facilities
- Integrated teams of formulation scientists, analytical experts, and regulatory professionals
- A partner mindset focused on meeting your milestones and accelerating market entry
