Clinical Supply Management
Clinical Supply Management
We are fully equipped to handle all your clinical supply chain needs. As your end-to-end clinical supply chain service provider, our clients encounter lower rate of failure and delays, saving you considerable time and money. Our service offerings include:
- Clinical supply chain consulting and management, including end-to-end project management
- Selection and procurement of all raw materials and packaging components for cGMP clinical supplies manufacturing, with all required regulatory documentation (vendor statements, letters of authorization)
- Phase-appropriate analytical method validation to support clinical supplies manufacturing
- Phase I clinical supplies manufacturing
- Phase II clinical supplies manufacturing
- Phase III clinical supplies manufacturing
- Placebo formulation development and manufacturing
- Clinical packaging, including blinded clinical packaging
- Release testing and generating COAs for clinical study materials
- Accelerated and real-time stability studies to support IND filing and clinical study shelf-life dating
- Complete IND writing, including CMC sections
- FDA IND submission.
- Export of clinical supply material to foreign countries (such as Europe, Australia, or India)
- Pilot or pivotal bioequivalence clinical supplies manufacturing for generic (ANDA filing)
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