FACILITIES

Validation Services

We can support your biotech and pharmaceutical commercialization through pivotal validation and compliance activities.

Services For Your Lab  /  Validation Services

Our team provides comprehensive validation services to the life sciences community. With a thorough understanding of biotech and pharmaceutical operations, and the regulatory challenges facing these industries, we have the experience, the skills, and the talent to provide efficient and cost-effective solutions.

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BIOPHARMACEUTICAL VALIDATION

Full compliance with regulatory requirements is the cornerstone of successful product development. From FAT support to high-level validation approaches to detailed on-site services, our professionals can help with:

FACILITY SYSTEMS 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
PROCESS EQUIPMENT VALIDATION
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
LAB/ANALYTICAL EQUIPMENT VALIDATION
Total Organic Carbon (TOC) Analyzers
Endotoxin Analyzers
High Performance Liquid Chromatography (HPLC)
COMPUTER SYSTEMS VALIDATION
Laboratory Information Management Systems (LIMCS)
Calibration & Validation Database Software
Deviation/Investigation/CAPA Management Software
Automated Process Equipment Software
Electronic Document Management Systems
MANUFACTURING PROCESSES VALIDATION & MORE
End To End Process Validation for GMP Biopharmaceutical Manufacturing Processes
Aseptic Process Simulations (APS)
  • Upstream (USP) Cell Culture Operations
  • Downstream (DSP) Purification Operations
  • Final Drug Product (FDP) Liquid Filling Operations
MASTER PLANS

An effective validation master plan ensures aligned expectations, informed commitments, and improved budgeting, scheduling, and project management. Our experts can help develop a plan to:

Meet Regulatory Requirements
Coordinate Commissioning, Qualification, & Validation Activities
Control Cost & Schedule
Ensure Best Practices

YOUR TRUSTED VALIDATION CONSULTANTS

YOUR GOALS

Whether you’re a start-up that requires high-level consulting about compliance, regulatory, or validation strategies or an established organization with targeted requirements for a specific project, you have a vision for achieving your organization’s milestones.

OUR APPROACH

We learn about your business, project, and methodologies, then provide you support with our technical skills, professional demeanor, and attention to detail. Our talented personnel are committed to understanding your needs and delivering practical validation, regulatory, and compliance outcomes.

INTEGRATED LABORATORY SERVICES

When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.