Ensuring Quality and Compliance
Discover GeneBio Partners' consulting services, designed to help life sciences companies thrive. We're dedicated to ensuring full compliance, maintaining inspection readiness, and sustaining product quality throughout the entire product lifecycle. Learn how our expertise can support your success.
Quality Assurance & Compliance
GeneBio Partners provides comprehensive quality assurance and compliance support tailored to life sciences companies. Our services cover the full spectrum of Quality needs, including CAPA management, root cause investigations, and inspection readiness. We also prepare teams with practical audit training, from how to respond to an auditor questions to what not to say. By combining training with QA oversight and Preventive quality measures , we help ensure your operations run smoothly and meet the highest standards.
CDMO & Outsourced MFG. Oversight
When you rely on a partner to manufacture your product, their performance directly impacts your success. GeneBio Partners provides hands-on oversight of contract development and manufacturing organizations to ensure they meet quality standards, and deliver reliability. From assessing audit readiness and performance trends, we safeguard your product quality and compliance, so you can scale with confidence.
Validation & Technical Support
Successful manufacturing starts with reliable validation. GeneBio Partners provides hands-on support for equipment and process validation, including IQ/OQ/PQ, equipment readiness and compliance reviews. We help ensure your systems are fit for use, fully documented, and inspection ready, minimizing delays, reducing risks, and supporting smooth scale up and commercialization.
"GeneBio Partners helped us navigate a critical FDA audit with stronger systems and a culture of compliance. Their expertise was invaluable!"
Client Testimonial