CGMP Validation Services

We provide cost-effective CGMP commissioning and qualification services for 503B, Cell & Gene, and traditional pharmaceutical manufacturing facilities. Our engineers have deep expertise in developing and implementing validation protocols (IQ, OQ, PQ), as well as preparing compliance documentation for equipment, utilities, processes, lab instruments, and computerized systems.

 

Commissioning, Qualification, Validation

Equipment | Utilities | Lab Instruments | Computer Systems

 

  • Refrigerators, Freezers, Incubators, Stability Chambers

  • Depyrogenation Ovens

  • Autoclaves

  • Blenders, Mixers, Agitators

  • Tablet Presses & Encapsulators

  • PECs (e.g., LAFW, BSC, RABS, Isolators, Powder Hoods)

  • Filtration Systems

  • Glassware, Parts Washers

  • Aseptic Processing Equipment

  • Capping Equipment

  • Inspection Systems

  • Label & Packaging Equipment

  • Water Systems (e.g., Water Chillers, PW, WFI)

  • Compressed Air & Gas Systems

  • HVAC Systems

  • Clean-In-Place Systems

  • Steam/Sterilize-In-Place Systems

  • Environmental Baseline Studies (EMPQ)

  • GC & HPLC Instruments

  • Weighing and Dispensing Systems

  • Laboratory Information Management Systems

  • Computer Systems

  • And More

 

We support facilities with risk-based, inspection-defensible CQV strategies that align with FDA and state expectations while avoiding unnecessary validation burden. Our approach integrates facility design, equipment qualification, process risk, and lifecycle management — not just protocol execution.

How Clients Use Us

  1. CQV strategy & scoping before validation begins

  2. Fractional CQV leadership during build-out, expansion, or routine requalification periods

  3. Design, execution and report writing of CQV programs

  4. FDA inspection preparation and remediation

 
Schedule a CQV strategy discussion →