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CAPABILITIES

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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.

SVP / LVP / Dosage Form Equipment
Critical Systems & Facilities
Medical Devices
Packaging / Labeling Equipment
Biotechnology
Computer Systems
Processes
Product Expertise

 

View our Capabilities Brochure for more information.

 


 

SVP / LVP / Dosage Form Equipment
  • Formulation Tanks
  • Mixers, Grinders, and Blenders
  • Sterilizing Filters and Sterilizers
  • Vial and Stopper Washers
  • Depyrogenation Ovens / Tunnels
  • Filling / Crimping / Sealing / Capping Machines
  • Lyophilizers
  • Refrigerators / Freezers / Incubators
Medical Devices
  • Management Review
  • Quality Systems and Gap Assessments
  • Design Controls
  • Internal Auditing
  • Supplier Management Systems
  • Assembly, Burn-in and Release Review
  • WIP, Laboratory, and Final Release
  • Metrics, KPIs, and Statistical Analysis
  • Complaints, CAPAs, and Recall
  • QMS and Annual GMP Training
Criticial Systems & Facilities
  • WFI and Purified Water Systems
  • HVAC System
  • Clean Steam System
  • Nitrogen System
  • Compressed Air System
  • Clean Rooms
  • Vacuum Systems
  • Pilot Plant
  • Clinical Scale
  • Commercial Manufacturing
  • Packaging and Labeling
  • Repacking
  • Warehouse and Distribution
Packaging / Labeling Equipment
  • Inspection Machines
  • Roll Label Counters
  • Label Machines
  • Vision Systems
  • Coders
  • Blister Packaging
  • Bar Code Readers
  • RFID Scanners
Processes
  • Aseptic Processes
  • Sterilization Processes
  • Cleaning Processes
  • Steam-in-Place Processes
  • Clean-in-Place Processes
  • Freeze-Drying Processes
  • Blow / Fill / Seal Processes
  • Fermentation Processes
  • Media Fill Processes
  • Barrier Technology
  • Chemical and Testing Laboratories
Computer Systems
  • BMS
  • LIMS
  • LANS / WANS
  • ERP (SAP, JDE, MAPICS)
  • PLC Systems
  • Calibration Data Base
  • Statistical Process Control

View our Computerized Systems Brochure for specific
information on our approach to meeting your needs.

 

Biotechnology
  • Bioreactors
  • Isolators
  • Aseptic Techniques
  • Clean Rooms
  • Contract Lab and Sterilizer Assessments
  • Change Management
  • Risk Analysis
Product Expertise
  • Pharmaceuticals, including:
    • Oral Solids
    • Liquids and Ointments
    • Sterile (SVP, LVP) Products
  • Medical Devices
  • Medical Diagnostics
  • APIs
  • Cosmetics