GMP and GLP Consultation

GMP Consultations:

We help you manage the challenges of Current Good Manufacturing Practices (CGMP), by guiding clients through FDA inspections. Our team includes industry veterans with product launch experience and backgrounds in development, scale up, validation and regulatory.

Our consulting philosophy involves team building and partnerships that combine substantial training with extensive project work. As your partner, our goal is to ensure that compliance is built into every operations process.

Our knowledge and practical experience can help your training program, operations and submission processes. Depending on your available resources, we can develop a customized approach to get your company ready for inspections, regulatory filings and product launches.

Our services include:
1. GMP Audits and System Development
2. Project Management for Facility Design, Engineering and Commissioning.
3. Product Development and Scale-Up Oversight.

GLP Consultations:

Any non-clinical laboratory facility you use to conduct product safety testing may be subject to inspection by FDA or other regulatory body. We can prepare you by performing independent audits of sponsor or contract facilities and studies, giving you additional assurance that a lab is in compliance with regulations. We provide GLP quality assurance services for the pharmaceutical, biotech, and chemical industries.

Our services include:
- Organization, personnel
- Facilities, Equipment, and Testing facilities operation
- Test and control articles
- Records, reports, and record/sample retention
- QA unit
- Protocol, data, and report audits
- In-process study inspections
- SOP and protocol compliance

Back to services