Pharmatek Laboratories offers GMP manufacturing of oral, parenteral and topical dosage forms. 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.
- 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 and liquid capsules, tablets, oral liquids, suspensions, emulsions, and dispersions
- Parenteral dosage forms including: IV, IM, and Subcutaneous
- Topical dosage forms including: creams and ointments
- Medical device coatings including: polymers and primers
|
- Clinical trial material manufacturing
- Batch record preparation and release
- Compounding
- Bulk packaging and labeling
- Release testing
- Analytical methods development
- Clinical trial material storage
- Stability testing
|
|
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. |
