Compliant operations must undergo validation to assure quality control measures satisfy the relevant standards. With an established history supporting the life sciences, pharmaceutical, and biotech industries, our consultants have demonstrated expertise with the latest guidance and regulations. We support various aspects of validation.
Building Management Systems (BMS)
Air Handlers Servicing GMP Suites
USP Purified Water
Water For Injection
Clean Steam
Compressed Air
Biokill Systems
Process Gas Manifolds
Commissioning Of Plant Steam, Chilled Glycol
Cell Culture Systems – Fixed Tank Fermenters & Bioreactors
Cell Culture Systems – Single Use Disposable Bioreactors
Biological Safety Cabinets
Tangential Flow Filtration (TFF) Systems
Chromatography Systems
Incubators
Clean Steam Sterilizers (Autoclaves)
Depyrogenation Ovens
Continuous Flow Centrifuges
Controlled Temperature Storage Units
Additional Equipment Not Featured
Total Organic Carbon (TOC) Analyzers
Endotoxin Analyzers
High Performance Liquid Chromatography (HPLC)
Laboratory Information Management Systems (LIMS)
Calibration & Validation Database Software
Deviation/Investigation/CAPA Management Software
Automated Process Equipment Software
Electronic Document Management Systems
Aseptic Process Simulations (APS)
Upstream (SAP) Cell Culture Operations
Downstream (DSP) Purification Operations
Final Drug Product (FDP) Liquid Filling Operations
End To End Process Validation for GMP Biopharmaceutical Manufacturing Processes
Meet Regulatory Requirements
Coordinate Commissioning, Qualification, & Validation Activities
Control Cost & Schedule
Ensure Best Practices
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