Achieve GxP Excellence
Pharmaceutical + Biotech Compliance
Holistic Roadmap to Compliance
Optimize Good Lab Practices (GLP) and Good Manufacturing Practices (GMP) facilities like never before. Confront compliance needs with a customized management strategy; deploy the right tools and team to operate with maximum efficiency and impact.
Our expert validation engineers bring end-to-end experience which includes validation of Quality Control (QC), manufacturing, and enterprise systems. And with our ability to staff entire organizations—from Quality Assurance (QA) to bench scientists and beyond—every step is streamlined.
Laboratory + Manufacturing Validation
Throughout each phase of operation— from Construction and Design to Standard Operating Procedure (SOP) authoring to Equipment Qualification—we simplify the path to validation.
Benefit from expert planning and comprehensive project and laboratory management tailored to your specific business needs. We support Food and Drug Administration (FDA)– and European Union (EU)-regulated labs and manufacturers with clarity throughout the validation process.
Computer Systems Validation
We’ve got you covered.
Stay on the cutting edge with comprehensive Computer System Validation (CSV) support. We collaborate with GxP stakeholders, Subject Matter Experts (SMEs), and vendors to ensure complete coverage for labs and manufacturers.
Let our team evaluate the system against 21 CFR Part 11 requirements and verify data integrity to ensure the system meets regulatory requirements. Achieve full qualification of the entire system, from Validation Life Cycle Authoring to Database Design and Enterprise System Upgrades. We even support periodic system reviews to keep you in compliance.
We do the heavy lifting, so you don’t have to.
Pharmaceutical Lab + Manufacturing Staffing
“Good Practice” requires great staff. Finding them just got easier.
Data Integrity + Remediation
There is no overstating how critical compliant data and Information Technology (IT) strategies are. The right tools and the right team are needed.
Beyond compliance, this is also what feeds company growth. Proper data management allows for intelligent scaling.
Our Experience Runs Deep.
Our clients include national Fortune 500 corporations and some of the nation’s best and brightest startups. Ground-up GxP or already established facilities—“good practice” is our expertise.
- Quality Control Laboratories
- Gene Therapy
- Vaccine Manufacturing
- Medical Device Manufacturing
- Contract Development and Manufacturing Organization (CDMO)
- Contract Research Organization (CRO)