Products and Services
Clinical Trial Materials (CTM) Manufacturing
Source:
Patheon Inc.
Our team of experienced development scientists formulate and produce required quantities of clinical trial materials for all stages of your molecule's clinical development plan.
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•Datasheet: Clinical Supplies Services
Our team of experienced development scientists formulate and produce required quantities of clinical trial materials for all stages of your molecule's clinical development plan. From simplified dosage forms in the earliest clinical stages to critical registration batches, our scientists optimize your formulation with your long term development program in mind. This can allow us to scale your product seamlessly through later phases of development and ultimately to commercialization.
•Datasheet: Clinical Supplies Services
•Datasheet: Clinical Supplies Services
Our team of experienced development scientists formulate and produce required quantities of clinical trial materials for all stages of your molecule's clinical development plan. From simplified dosage forms in the earliest clinical stages to critical registration batches, our scientists optimize your formulation with your long term development program in mind. This can allow us to scale your product seamlessly through later phases of development and ultimately to commercialization.
Our Quick to Clinic™ programs rapidly accelerate your molecule to First Time in Human (FTIH) studies using minimal amounts of your valuable Active Pharmaceutical Ingredient (API).
Clinical trial manufacturing and packaging services include:
- U.S., EU, Japanese and other market standards
- Phase I, II, III & registration clinical supplies
- Full CTM formulation, manufacturing, packaging and release testing
- IND (Investigational New Drug Application) support documentation
- Qualified Person (QP) at every European site to release materials for use in EU
- Full specification retesting and/or identification testing available at European sites for importation into the EU from North American sites
- Full quality support for all clinical materials
•Datasheet: Clinical Supplies Services
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