Cedric Drouet

Cedric Drouet is a seasoned Regulatory Consultant at ExFDA Consultants, where he leverages over five years of expertise in Quality Assurance and Quality Management Systems (QMS) within the pharmaceutical industry. His current role involves guiding pharmaceutical and biotech companies through complex regulatory pathways to achieve product approval and ensure ongoing compliance throughout product lifecycles. Cedric’s deep understanding of regulatory frameworks, combined with his proficiency in audit quality, risk management, and compliance strategies, positions him as a trusted advisor for clients navigating the evolving landscape of pharmaceutical regulation.

At ExFDA Consultants, Cedric plays a pivotal role in managing key projects that focus on regulatory submissions, inspection readiness, and quality system optimization. His expertise in implementing and maintaining robust QMS, utilizing tools like TrackWise, SAP, and LIMS, ensures that clients adhere to stringent industry standards such as GMP, GCP, and GLP. Cedric’s background in assurance qualité and audit qualité enables him to identify potential compliance gaps proactively and develop strategic solutions to mitigate risks.

His technical skill set extends to specialized software platforms like Phenix, eBRS, and ZAC, which he employs to streamline documentation, track deviations, and facilitate effective CAPA processes. Cedric’s comprehensive approach combines project management, regulatory intelligence, and quality assurance to help clients not only gain product approval but also sustain compliance in a highly regulated environment. His dedication to excellence and continuous improvement makes him a vital asset to ExFDA Consultants and the pharmaceutical industry at large.