Services

Quality Control: 

· Laboratory operations management for efficiency, effectiveness, and regulatory (cGMP) compliance and regulatory inspection preparedness, for lot release, product stability program, and in process control. 

· Qualification / verification / validation of analytical methods (biochemical, physical, microbiological, in vivo, in vitro) for product release and stability of drugs, biologics, and vaccine products. 

· Environmental and utilities monitoring, qualification, and investigation of manufacture of biologics, drugs, and vaccine products 

Regulatory and Quality 

· Compliance to cGMP, 21CFR, USP/EP, and ICH regulations 

· Preparation for CDER, CBER, EMEA inspection. 

· Preparation and review of CMC sections of NDA, PLA, MAA filings 

Technical Expertise 

Extensive experience managing all aspects of analysis of product quality covering in process monitoring and bulk and finished product lot release and stability, environmental monitoring of aseptic processes and pharmaceutical utilities, applying a range of analytical methodologies; in vivo and in vitro biosafety, cell culture bioassays, immunochemistry, microbiological, chromatography, electrophoresis, and chemical/biochemical methods.