cGMP Clinical Manufacturing
Fully compliant cGMP manufacturing for clinical phase 1-3 across a wide range of oral solid and liquid dosage forms
Your clinical plan is the bridge from concept to real therapeutic benefit, and getting quality cGMP clinical supplies when you need them is crucial to success. Every batch matters because patient safety and study integrity depend on consistent, high-quality drug product that meets specifications and regulatory compliance requirements.
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What We Offer
We manufacture cGMP clinical supplies for a wide range of dosage forms at scales ranging from a few dozen dosage units for phase 1 to multiple large-scale batches for complex multicenter phase 3 studies.
We understand that clinical manufacturing is different from both engineering and commercial manufacturing in important ways. Clinical batches often involve tight timelines, limited material availability, and limited manufacturing experience. From study to study, there can be differences in scale, unit operations, process parameters and formulation composition.
Attention to detail is essential.
Our Approach
- Phase-appropriate controls
- Our quality systems are designed to be appropriate to the clinical phase you’re working on. We aim to have sufficient controls in place to ensure that the batches are manufactured, sampled, stored, tested, and thoroughly documented according to cGMP standards, while flexible enough to accommodate necessary and appropriate changes.
- Transparent communication
- When issues or questions arise, we communicate proactively and promptly. Time is of the essence. Some situations can be corrected with prompt action that would be much more difficult in a retrospective investigation. Regardless of the situation, prompt and open notification enables you to be fully informed so you can make timely decisions.
- Regulatory readiness
- Our documentation, from batch records to test results, is prepared with regulatory inspections in mind. We know how important proper, accurate, and timely documentation is to answering review or inspection questions that may arise months or even years after the work is done.
- Supply continuity
- We work closely with you to plan for your clinical supplies. Timing is everything. We understand that supplies made too early are wasting shelf life while supplies provided too late can lead to clinical delays or out-of-stock. A lot is riding on having the product you need when you need it in the clinic.
Design • Develop • Manufacture
Let's build something remarkable