FACILITIES
Validation & Compliance
We can support your biotech and pharmaceutical commercialization through pivotal validation and compliance activities.
Services For Your Lab / Validation & Compliance
Late-Phase Commercialization Consulting
Successful compliance requires knowledge of the current regulatory environment, effective quality assurance, and risk management. Our services include:
Effective validation master plans should align expectations, improve budgeting, and inform project management. Our experts can help develop a plan to:
Full compliance with regulatory requirements is the cornerstone of successful product development. From Factory Acceptance Test (FAT) support to high-level validation approaches to detailed on-site services, our team support:
Ensuring your application or submission represents your work accurately and thoroughly often requires an extra set of eyes. Our consultants can support:
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.
CDMO Services
RESOURCES
TERMS
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
CLEANROOM GUIDES
ISO 14644-1 Cleanroom Standard
EU Guidelines to Good Manufacturing Practice
CERTIFICATIONS
A2LA, BSI, CETA, ISO9001, NEBB
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To help ensure compliance with USP General Chapter <797> and USP General Chapter <800>, our CETA National Board of Testing certified staff provide all required pharmacy cleanroom testing and certification.