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Pace Analytical
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Validation Services

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