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Validation Services

Professional Services / Facilities / Validation and Compliance

Validation and Compliance

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:
Pace Scientist working in laboratory. Validation service, Validation consultant, GMP validation, GxP validation, Process validation
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
  • 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
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 Professional Services

When your team needs additional support, we are ready to jump in to meet demand. Our diverse range of regulatory experts allows us to aid in a variety of projects and programs.