Your Partner in GxP Quality & Compliance for Life Sciences Industry
We provide GxP expertise & tailored Quality Solutions on site / remote / hybrid
Our Mission:
We provide customized GxP QA support and quality solutions tailored to your specific needs. We aim to build and maintain a sustainable partnership with you throughout the stages of R&D, preclinical, and clinical studies (phases 1 to 3) up to commercialization.
We are driven by a passion for continuous improvement and innovation.
Who we are:
MF Life Sciences GxP Consulting GmbH, based in Basel, Switzerland, is a specialized consulting firm focusing on GxP compliance. Founded by Mylène Fleurant in 2019, we provide customized and sustainable GxP services and solutions to the Life Sciences, Pharma and Medical Devices sectors.
What we offer
Business Cases
The Situation
A biopharmaceutical firm was in the process of starting a phase 3 in oncology using a CRO with a limited QA team and legagy QMS & SOPs.
What MF Life Sciences GxP Consulting did?
We provided on site interim Head of QA to redefine and restructure the GxP QA organization, enhanced the QMS & existing SOPs and established the required SOPs related to Suppliers oversight.
Results
A fully compliant QMS supported by a robust GxP QA organization enabled the firm to successfully pass due diligence audits. All areas of the company were well-prepared, and employees were ready to provide answers to the questions for which they had been trained.
The Situation
A newly created biotech startup company acquired a molecule already developed in phase 1 and started a phase 2/3 in oncology using CROs and CMOs.
What MF Life Sciences GxP Consulting did?
Based on timelines from the customer, we built a lean QMS & SOPs which focus on the oversight of CROs and CMOs, implemented a GxP audit program and qualified & monitored the Suppliers.
Results
The company successfully navigated their Suppliers’ oversight during phase 3 using an agile QMS & SOPs with an appropriate Clinical QA oversight on the Clinical Development activities & GMP QA oversight on CMC activities.
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