Summary

Biopharmaceutical, analytical, GMP, method development, method validation, software validation, environmental monitoring (EM), stability testing, E&L testing, quality control

Description

Provide consulting services to the Biopharmaceutical industry, specializing in analytical sciences under Good Manufacturing and Good Laboratory practices (GMP & GLP). Consulting services are based on 30+ years as the leader of numerous CRO and CDMO firms for all aspects of analytical sciences supporting manufacturing of regulatory compliant products used in the pharmaceutical industry. Built 4 different GMP and GLP compliant laboratories for reporting regulatory compliant data for use in biopharmaceutical products for human and veterinary use.

Special details

The most recent was building and leading a Quality Control analytical lab for a prime contractor to the DOD to support manufacturing of biopharmaceutical products as well as BSL3 vaccines. Building all such laboratories required staffing, installation, qualification and validation of all methods, instruments, associated software, training and oversight to support lot release, stability and all other associated tasks. Analytical techniques ranged from numerous chromatographic, electrophoretic, mass spectroscopy, general spectroscopy, cell based bioassays, immunological, physical tests, PCR, next generation PCR (NGPCR) and all microbiological methods supporting environmental monitoring (EM) and product release.

Profile

  • Incorporated in
    Florida
  • Established since
    2018
  • Main/Branch
    Branch

Address

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