We have had the privilege of partnering with GxP Cellators for the past five years, during which time they have provided invaluable oversight of our quality and regulatory programs. Their expertise was instrumental in setting up our parent manufacturing site, which currently meets FDA and Health Canada-GMP standards. We are pleased to report that GxP Cellators is now assisting us in establishing a second manufacturing site that will generate GMP-grade CBD Isolates for clinical use. This is an exciting development for our research, and we are grateful for the continued support of GxP Cellators in this endeavour.

We engaged GxP Cellators to assist us with preparing for an FDA Inspection, and we could not have been more impressed with their services. The team demonstrated a high degree of diligence and thoroughness, ensuring that all of our documentation was in order and that all necessary CAPAs had been implemented. Additionally, they took the time to provide invaluable coaching to our staff on CAPAs and interview techniques. We found the consultants to have an impressive range of skills and knowledge, which proved immensely beneficial to our organization. Overall, we highly recommend GxP Cellators to organizations seeking professional and effective assistance preparing for regulatory inspections.

We received excellent assistance from GxP Cellators in creating the CSV documentation necessary for validating computerized systems such as NovaLimbs, e-QMS Vault, and the ERP system. The consultants we worked with were highly knowledgeable about recent regulatory requirements and were proactive in keeping us informed. GxP Cellators completed the project well within the agreed-upon timeline. Overall, we were delighted with their work.

GxP Cellators oversees the quality and regulatory operations of our GMP-transition project. They designed the required quality management system and validation documentation for Phase 1 and we’re now in Phase 2. The project is going smoothly. Great job, GxP Cellators team!

Our organization contracted GxP Cellators for technical writing services on laboratory investigations, which helped us close open cases promptly with expert technical and regulatory advice. We signed a multi-year contract with GxP Cellators for regular quality support and staff mentoring on regulatory standards.

The expertise of GxP Cellators was instrumental in facilitating our site readiness programs. Their contributions included the design of site validation documentation and the development of regulatory strategies for our manufacturing operations. The team’s professionalism and focus on results were highly commendable and contributed to the successful completion of our program. We wholeheartedly endorse GxP Cellators and their services.

Our experience with GxP Cellators has been highly positive. The team at GxP Cellators provided us with invaluable assistance in redesigning our Quality Management System (QMS), which proved instrumental in successfully submitting our class-III medical devices application to the regulatory body. Throughout the QMS redesign process, we were introduced to a team of highly competent and experienced consultants who approached our project with the utmost diligence and professionalism. Their proactive approach enabled us to establish the necessary standard and obtain the ISO 13485 certification, which was crucial in gaining approval for our class III medical devices. We are grateful for the expertise and guidance provided by GxP Cellators and would highly recommend their services to other organizations needing similar assistance.