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.
Biopharmaceutical 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
- 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
- Total Organic Carbon (TOC) Analyzers
- Endotoxin Analyzers
- High Performance Liquid Chromatography (HPLC)
- Laboratory Information Management Systems (LIMCS)
- Calibration & Validation Database Software
- Deviation/Investigation/CAPA Management Software
- Automated Process Equipment Software
- Electronic Document Management Systems
- 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
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.