Capabilities

As advisors to FDA regulated pharma, biotech, medical device, and diagnostics companies all over the world, we know that effective quality assurance, validation, and regulatory compliance are essential. And we know that our customers want to accomplish objectives associated with these functions as proficiently as possible.

But we also believe in doing it right – the first time. Every time. We use a process that focuses on both quality and efficiency. Not just because it’s the right thing to do. But also because we’ve proven that it works. This is what we do.

  • Chemistry Laboratories
  • Clean Rooms
  • Clean Steam Systems
  • Clinical Manufacturing
  • Commercial Manufacturing
  • Compressed Air Systems
  • HVAC Systems
  • Microbiology Laboratories
  • Nitrogen Systems
  • Packaging & Labeling
  • Pilot Plant
  • Repackaging
  • Vacuum Systems
  • Warehousing & Distribution
  • WFI & Purified Water Systems
  • Compression Machines
  • Depyrogenation Ovens / Tunnels
  • Encapsulators
  • Filling / Crimping / Sealing / Capping Machines
  • Film / Spray Coaters & Dryers
  • Fluid Bed Dryers
  • Formulation Tanks
  • Isolators
  • Lyophilizers
  • Mixers, Grinders, & Blenders
  • Refrigerators / Freezers / Incubators
  • Sterilizing Filters & Sterilizers
  • Tray Dry Ovens
  • Vial & Stopper Washers
  • Bar Code Readers
  • Blister Packaging
  • Coders
  • Inspection Machines
  • Label Machines
  • RFID Scanners
  • Roll Label Counters
  • Vision Systems
  • Aseptic Processes
  • Barrier Technology
  • Blow / Fill / Seal Process
  • Chemical and Testing Processes
  • Cleaning Processes
  • Clean-in-Place Processes
  • Encapsulation
  • Fluid Bed Technologies
  • Fermentation Processes
  • Freeze-Drying Processes
  • Media Fill Processes
  • Steam-in-Place Processes
  • Sterilization Processes
  • Suspensions / Emulsions
  • Tableting
  • Assembly, Burn-in & Release Review
  • Complaints, CAPAs, & Recalls
  • Design Controls
  • Internal Auditing
  • Management Reviews
  • Metrics, KPIs, & Statistical Analysis
  • QMS & Annual GMP Training
  • Quality Systems & Gap Assessments
  • Regulatory Strategy & Remediation
  • Supplier Management Systems
  • WIP, Laboratory, & Final Release
  • Aseptic Techniques
  • Bioreactors
  • BLA Submissions
  • Centrifugation Downstream Processing
  • Change Management
  • Clean Rooms
  • Contract Lab & Sterilizer Assessments
  • Microbiology Controls
  • BMS
  • Calibration Data Base
  • CAPA / Complaint Systems
  • ERPs (SAP, JDE, MAPICS)
  • LANs / WANs
  • LIMS
  • PLC Systems
  • Statistical Process Control
  • Biologics & Biotech
  • Devices & Diagnostics
    • Combination Products
    • Electromechanical Devices
    • Firmware & Standalone Software
    • IVD Systems & Reagents
    • LDTs
  • Nutritionals & Dietary Supplements
  • Pharmaceuticals
    • APIs & Bulk Chemicals
    • Liquids & Ointments
    • Oral Solids
    • Sterile (SVP, LVP) Products