Once a clinical formulation is developed, the decision of where to manufacture clinical supply is critical to maintaining product development timelines and ensuring product quality. Specialization in Phase I/II manufacturing provides a unique advantage to clients seeking to manufacture clinical supply material using current Good Manufacturing Practices with necessary regulatory compliance.
Pharmatek's focus on early phase development enable us to be flexible and responsive to your manufacturing needs. Clients can depend on on-time delivery of clinical trail materials and trouble-free technical transfer for phase III and commercial scale-up.
- Pre-formulation solubility and stability evaluations
- Comprehensive excipient screening
- Prototype development
- Formulation optimization and finalization
- Supporting documentation and data package
- Oral dosage forms including:
- Solid (tablets and capsules)
- Liquid-filled capsules
- Oral liquids
- Wet & dry granulations
- Hot melt granulations
- Fluid bed coating
- Powder in a capsule/bottle
- Drug product release & stability testing for injectables
- Clinical trial material manufacturing
- Batch record preparation & release
- Individual & bulk packaging/labeling
- Release testing
- Analytical methods development
- Cleaning method development
- Clinical trial material storage & distribution
- Stability testing
- USP/EP testing including: pH, osmolality,clarity, volume in container for injectables
- Scale-up & technical transfer studies for injectables
Quality control provides necessary test information prior to, during and post-manufacturing. Our quality control team is responsible for assay transfer, qualification and validation, raw materials testing, environmental monitoring and microbiology, in-process assays, product release testing and executing product stability studies.
Click here for a list of Pharmatek's manufacturing equipment
In producing clinical trial supplies, Pharmatek's manufacturing team is versatile enough to efficiently manage small batch manufacturing as well as large, complex clinical trial studies. Manufacturing the product to quality standards with on time delivery is a given. The added benefits such as no hassle scheduling, rapid batch record release and reporting, efficiency in technology and methods transfer all contribute to our high client satisfaction in manufacturing projects.