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Facility Qualification Services

Professional Services / Facilities

Certified Facilities Validation Services & Equipment Qualification

Maintain operations and minimize downtime with our facility validation and equipment qualification services. Our integrated facility qualification services include a range of support options to consolidate your partnerships and satisfy relevant quality standards. We understand your challenges and know that ongoing, compliant operations are critical to your business’ success. By pairing decades of laboratory and CDMO management experience, we offer customizable solutions to fit your unique needs.

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Supporting Optimal Operations & Compliance

Cleanroom Testing & Certification

Whether you plan to launch a new space or simply want to maintain your existing facilities, our team has the comprehensive knowledge and experience to ensure your facilities adhere to stringent regulatory requirements. We perform testing in line with cGMP, IEST, and ISO.

Validation Services

Our team understands the regulatory challenges that biotech, pharmaceutical, and medical device operations face, and we have the experience, skills, and talent to provide you efficient and cost-effective solutions.

Environmental Monitoring

Our environmental monitoring services demonstrate a state of control to maintain the quality and safety standards essential to your operations. We offer support at any stage, including new facilities, remediation, shutdowns, or ongoing manufacturing.

Laboratory Relocation

We work to holistically understand your lab’s unique needs and create a tailored, comprehensive relocation plan around your precise laboratory workflows. From start to finish, your move is managed to minimize downtime.

Integrated Laboratory Services  

Maintain compliant, ongoing operations with our array of talented teams. We have the people power to upkeep your facilities and instrumentation, achieve regulatory compliance, staff your projects, and outsource your research and development.

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

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.