Redefining the CDMO Model: End-to-End Solutions with Greater Flexibility
Years of Client Satisfaction
Pharmaceutical Development & cGMP Lab Services Appropriate for Start-ups to Big Pharma
- More than consulting. More than a testing lab. CMC’s laboratories and pilot plant shorten the timeline of drug product development. Services include:
- Pre-formulation & formulation development
- Analytical method development & validation
- Drug delivery system design
- Stability evaluations & compatibility testing
- Prototype preparation for in vitro & in vivo studies
- CMC development for all clinical phases
With integrated regulatory support, our goal is to ensure success for your drug development pipeline. We navigate the complexities of pharmaceutical development while helping you prepare and respond to FDA requests and submit the best data for your regulatory submissions (INDs, NDAs, ANDAs, and more).
A Collaborative Partner, Not Just a Vendor
Tailored Solutions to De-risk Your Pipeline
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Frequently Asked Questions.
Unlike other CDMOs, we don’t lock you into a specific technology, dosage form, or manufacturing capability. We also prioritize early-stage programs, and don’t put them on the back burner until a product is ready to manufacture at commercial scale.
Our flexible and proven model gives you access to a full-service development lab with integrated regulatory expertise that ensures seamless scale-up and tech transfer. We then identify, qualify, and manage the cGMP manufacturer, effectively granting you end-to-end support without unnecessary limitations.
We operate a pilot plant for non-GMP small batch production (100’s of units) of drug products, ideal for pre-clinical studies. CMC Pharma does not own a commercial GMP manufacturing facility. Instead, we oversee scale-up, tech transfer, and CMO qualification, ensuring that your product is manufactured at the most appropriate partner site, and under strict cGMP compliance. We manage every CMC-related aspect of your program, from formulation development through execution of CMO quality agreements and oversight. This reduces risk while accelerating timelines. Plus, there are fewer handoffs, preventing costly delays and communication issues.
The earlier the better! Our scientists design stage-appropriate studies that de-risk your pipeline and save costs later in development. Many of our clients engage us as early as pre-formulation, but we also support projects at IND, NDA, or post-approval stages. We offer tailored solutions specifically tailored to your immediate or long-term program objectives.