Valériane Levelut, PharmD, ERT, DABT

Valériane is a Pharmacist, specializing in regulatory toxicology and with experience in cosmetics, food, chemicals, biocidal products and medical devices. Prior to joining NAMSA in 2020, Valériane worked for different Contract Research Organizations (CROs) where she was responsible for the safety assessment of various types of consumer products. She also has strong experience in worldwide regulations (including Europe, the U.S. and Asia), helping manufacturers obtain regulatory approval of their products in different regions.

Valériane holds a Master’s Degree (MSc) in Toxicology and obtained the Eurotox (ERT) certification in 2019; she has also been a Diplomate of the American Board of Toxicology (DABT) since 2021.

CORE COMPETENCIES

• Preparing toxicological risk assessments, biological evaluation plans and reports in compliance with ISO 10993-1, ISO 10993-17, ISO/TS 21726 and ISO 14971 for submissions to the U.S. Food and Drug Administration (FDA), other regulatory agencies and Notified Bodies (NBs)
• Evaluating biocompatibility and general toxicology data to ensure compliance with relevant regulatory requirements and standards
• Working knowledge of FDA, EU Medical Device Directive (MDD), EU Medical Device Regulation (MDR) and other global medical device regulations and/or biologics regulations, ISO 10993 series and ISO 14971
• Ensuring biocompatibility studies are in compliance with most recent regulatory requirements
• Providing technical support to laboratory staff
• Advising Clients on technical issues related to biocompatibility and material characterization
• Providing support to Clients on deficiencies and questions received from regulatory agencies and NBs and participating in FDA meetings
• Performing biocompatibility gap analyses
• Performing and summarizing literature searches
• Evaluating and determining biological relevance of unexpected results
• Performing toxicity predictions using computational (quantitative structure-activity relationship [QSAR]) models in compliance with ICH M7 and ISO/TS 21726 requirements

RECENT PROJECTS

• Participated in the CE-marking of several medical devices by ensuring biocompatibility was appropriately evaluated according to current regulatory and normative requirements
• Participated in the regulatory approval of vascular stents in Europe and the U.S. (Premarket Approval [PMA]) by answering deficiencies from the authorities related to biocompatibility
• Successfully participated in PMA supplement of a pediatric device following discussions with the FDA