International Companies
Seeking to understand and meet French and European regulatory requirements for their health products with operational support, not just theoretical guidance.
Who we work with
Very different situations, one common need: moving forward with clarity in a complex regulatory environment.
R&D, Marketing and Innovation Teams
Looking for an external perspective to unblock a situation, secure a decision or explore a new market without getting lost in regulatory complexity.
Startups
and SMEs
Developing medical devices, diagnostics or care and wellness products for human health, animal health, or both and needing a regulatory partner to structure their project and move forward without unpleasant surprises.
Investors
Looking to assess the potential and regulatory risks of an opportunity before investing whether as part of a formal due diligence process or an initial strategic assessment, whether in a human health startup or an animal health industry player.
Any Company Facing a Qualification Question
Particularly for “borderline” products, where the answers are never straightforward and where field experience makes all the difference as well as service providers, subcontractors and distributors looking to structure their quality approach to meet the expectations of their clients in the healthcare sector.
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Mission
Lifting regulatory uncertainties. Anticipating risks. Identifying the opportunities that regulatory complexity can cause companies to miss.
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Our Founder
Sandra Dejean, PharmD, Certified Lead Auditor ISO 13485. 20 years of field experience. Winner of the Académie Nationale de Pharmacie Thesis Prize 2016.
Let’s
take action
A project to launch, a situation to unblock, a decision to secure?
The first step takes just 15 minutes. Let’s talk – no commitment.
