We help you realize your ideas

Management and coordination of diverse equipment qualification, spanning from laboratory analyses to upstream and downstream processes. We managed all communication with suppliers and services providers, while also supporting the site Project Manager in scheduling activities and coordinating between different actors of the new site. Our responsibilities encompassed generating and revising protocols, executing qualification protocols, reviewing results, documenting and mitigating deviations, and generating reports. Additionally, we contributed to the generation and revision of Standard Operating Procedures (SOP).

Commissioning and validation project management for a new biotechnology manufacturing site (Clinical Phase I). Our responsibilities included planning and following up on the schedule, monitoring the budget, and any revaluation of the mandate. We served as the main line of communication between the engineering firm, construction, and validation teams. Additionally, we coordinated trainings, access, and technicalities for all validation consultants on site and were responsible for the overall completion of the validation project.

Defining needs, configuration, commissioning, and validation of a computerized laboratory sample management system. Our services included vendor qualification, GxP assessments on the software, software configuration according to client requirements, and staff training. We also wrote a CSV Validation Project Plan (VPP), DS, and other specifications, as well as SOPs for the new software. Additionally, we reviewed supplier qualification documents, wrote and executed complementary CSV tests, as well as qualification reports. Our role encompassed project management, scheduling, conducting weekly progress meetings, and diligent follow-ups to ensure success.

We wrote, audited and reviewed the entire quality system for the client. It included SOPs generation, supplier audits and qualifications, equipment and software qualification, CAPA & change request, maintenance and calibration, and business continuity. This project was part of the client preparation for ISO 9001 certification.

End-to-end management of a smoke test project in a pharmaceutical sterile environment. From conceptualization to Health Canada approval, we oversaw every aspect. Managing timelines, schedules, and personnel, we ensured seamless operations. Our services encompassed protocol generation, approvals, follow-up, and meticulous documentation support. We also coordinated with an external film company for pre-execution organization and conducted comprehensive video reviews post-
execution for the regulatory submission.