We help you realize your ideas

Our consulting engineering company offers a wide range of services in pharmaceutical & biotechnological industry. With our flexible business strategy, we propose a quick resources mobilization and a transparent execution.

Our services‍

Qualification Validation

· Cycle de vie
· Equipements, procédés et instruments de laboratoire
· Services ingénierie

Validation Informatique

· Intégrité des données électroniques
· Support
· Validation de logiciels

Validation Nettoyage

· Analyse de risques
· Plan de Validation et matrice
· Support méthodes analytiques

Gestion de Projet

· Accompagnement transferts R&D vers commercialisation
· Budgets, échéanciers, ressources
· Coordination d’équipe

Assurance Qualité

· Audits
· Formations BPF & AQ
· Implémentation de système qualité
· Rédaction documentaire
· Préparation à l'obtention de la certification ISO-9001

Affaires Réglementaires

· Analyses de risques
· Licences

Dessins Techniques

· Arpentage
· Création ou mise à jour de plans techniques

Our significant projects

Major challenges faced by our firm in recent years

Vaccines industry CQV

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).

Sterile products manufacturing industry commissioning

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.

Laboratory software configuration, commissioning and validation (CSV)

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.

Quality System implementation

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.

Smoke test protocol

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.