Whether for a first-in-human batch or a Phase III program, we support you with adapted industrial capacities in compliance with GMP standards.
Leveraging our experience, we support biotechs and laboratories by offering them the flexibility, responsiveness, and security they require.
We cover all clinical manufacturing needs, from Phase I to III:
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✓ GMP manufacturing of clinical batches |
Flexible volumes to support you through all phases of your clinical study, from Phase I to Phase III. |
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✓ Development and production of placebos |
Unither Pharmaceuticals possesses true expertise in the development and manufacturing of placebos that are strictly similar to the reference product for your clinical trials against placebo. |
We integrate clinical manufacturing into a global approach.
Your product progresses in a controlled environment, with complete traceability and documentary continuity.
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Anticipation of critical production parameters
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Pilot-scale process validation
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Structured technology transfer
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Preparation for industrial scalability
Over 30 years of experience in clinical manufacturing and pre-commercial development
Certified GMP sites adapted for small and medium-scale batches
A dedicated project team for your program
Proven ability to support Phases I, II, and III
Yes. We develop and manufacture placebos that are strictly identical to the corresponding product.
Our sites are equipped for clinical volumes: from a few dozen to several thousand units, or from a few liters to several kilograms, depending on the technology and protocol.
We do not perform full clinical labeling or randomization.
However, we can provide ‘blind’ marking, where the only product identification is on the box.
This process is designed to facilitate the work of specialized partners who handle multilingual labeling, randomization, and distribution to trial centers.
Outsourcing the manufacturing of a drug or medical device to a CDMO offers increased flexibility, reduced time-to-market, and access to specialized technical and regulatory expertise.
An experienced CDMO also offers certified industrial facilites that are adapted to every phase: scale-up, validation, commercial production, post-MA transfer, etc.
