Pharmatek: Pharmaceutical Chemistry Development specializes in compound selection, analytical development and formulation development. Based in San Diego, Pharmatek is known for it's own Hot Rod Chemistry and Formulation Screening Kit.
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
Formulation optimization and finalization
Supporting documentation and data package
GMP Manufacturing Capabilities:
Oral dosage forms including:
Solid (tablets and capsules)
Wet & dry granulations
Hot melt granulations
Fluid bed coating
Powder in a capsule/bottle
Drug product release & stability testing for injectables
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.
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.