A highly-skilled team, commited to taking action

We are a highly technical team with extensive scientific expertise and in-depth knowledge of the full spectrum of early drug development, regulatory constraints, and commercialization. We provide tailored services to our clients. We have an expert for every aspect of the regulatory process, from pre-approval through to post-marketing activities (PV, supply…).

You have a problem: we solve it. We are more than consultants: we take action/we get things done. We build on our clients’ practices to serve them better. With over 3,000 completed assignments, we have proven our effectiveness and ability to solve complex problems for our clients.

We are all driven by scientific curiosity, humility, kindness, and a strong commitment to improving health.

3,000 health improvement missions accomplished

Meet our management team, a seasoned group of professionals with an entrepreneurial mindset and over 30 years of experience in the pharmaceutical industry.

Stéphane Simon VP Chief Pharmaceutical Officer
Hélène Rouquette Founder of IDD and Biovalys
Nicolas Crespo VP Chief Operating Officer
Bénédicte Bérardo Development & Industrial Affairs Director
Emmanuelle Brun Development & Regulatory Strategy Director
Anne Walter Pharmaceutical Affairs and exploitation Director

Stéphane Simon

VP Chief Pharmaceutical Officer

Stéphane Simon has over 29 years of experience in the pharmaceutical industry, holding senior regulatory positions. A Qualified Person (Responsible Pharmacist) since 1997, he has developed deep expertise in GxP environments across healthcare sectors, and provided strategic regulatory guidance to optimize asset development and lifecycle management. Stéphane joined IDD in 2025, as VP Chief Pharmaceutical officer. His main mission is to design and implement transformations, to manage international teams, and to regularly interact with health authorities.

Hélène Rouquette

Founder of IDD and Biovalys

Hélène is a Doctor of Pharmacy and hold an MBA in Finance & Management from ESCP Europe. With nearly 40 years in drug development, including leadership roles in major pharmaceutical companies, she founded IDD in 2003, a consulting firm dedicated to regulatory affairs and development strategy. IDD is now a trusted partner for pharmaceutical and biotech companies seeking regulatory approval in Europe and the US.

Nicolas Crespo

VP Chief Operating Officer

Nicolas Crespo has over 20 years of experience in the pharmaceutical industry and consulting. He joined IDD in 2023 as project manager. He has served as an MSL for hospital-marketed medicines. Appointed VP Chief Operating Officer, Nicolas  has led the development and registration of small and large molecules up to marketing authorization. He has also contributed to multiple licensing-in due diligences and built roadmaps for industrialization and registration. Regularly interacting with EU health authorities, he works to streamline market access. Nicolas has a strong network of KOLs and has established scientific committees across various therapeutic areas.

Bénédicte Bérardo

Development & Industrial Affairs Director

After having held R&D executive positions as Director of Development and Program Director, Bénédicte has a strong track record in the development of generic products, whatever the pharmaceutical forms, up to MAs.  She owns a proven polyvalence in chemistry of active ingredients, analytical development, formulation development, industrial transfer and bioequivalence. She managed teams interacting with API manufacturers, CDMO, CMO and CRO, in and outside Europe. She is committed to providing solutions to complex problems within tight deadlines.

Emmanuelle Brun

Development & Regulatory Strategy Director

Through her previous executive positions as International Technical Project Director, CEO of a CDMO and Qualified Person, Emmanuelle developped a solid track-record in driving  drug development projects, with strong skills in analytical and formulation development and high quality ,customer focus and business awareness mindset. She enjoys managing a multi-disciplinary team of confirmed consultants defining development and regularory strategies and providing operational lead for CMC, Non-clinical and Clinical activities from early development plan to MAA submission, including among others preparation of Clinical Trial Application and Scientific Advice.

Anne Walter

Pharmaceutical Affairs and exploitation Director

Anne Walter has over 30 years in the pharmaceutical industry, holding senior positions in Regulatory Affairs. She joined IDD in X as Director of Pharmaceutical Affairs and Exploitation. With her background in Quality, Pharmacovigilance and Compliance, Anne brings a broad and international vision of the pharmaceutical industry. She manages both consulting and industry teams, organize and structures GxP-compliant departments across functions. She has been a Qualified Person during 12 years and is familiar with NCAs interactions.

Together, these departments deliver end-to-end support across the pharmaceutical product lifecycle; from concept to commercialization and beyond.

Development & Strategy

This is the starting point. The first department focuses on developing the drug and planning its path to approval. It handles:

  • Defining the overall development and regulatory strategy for a new drug.
  • Managing all the technical studies required, using integrated expertise in preclinical, CMC (Chemistry, Manufacturing, and Controls), and clinical phases.
  • Preparing the initial dossiers for clinical trial applications with the EU and FDA (CTA/IND).

Essentially, this team turns a promising molecule into a viable candidate for market approval.

Regulatory Approval & Lifelong Compliance

Once the drug is developed, the second department takes over to secure and maintain its legal status. It manages:

  • The core registration strategy and submission of key approval dossiers (like an NDA or BLA) to Health Authorities.
  • The entire product lifecycle, including post-approval changes and variations.
  • Broader business activities like due diligence for portfolio acquisitions and mergers & acquisitions.
  • Ongoing compliance, from GxP audits and inspection readiness to full pharmacovigilance (safety monitoring).

This team is the central hub for all regulatory matters, ensuring the product gets approved and stays compliant throughout its life.

Commercialization & Market Operations

After the drug is approved, the third department provides the infrastructure to sell and distribute it. It offers a:

  • Ready-to-use commercial operating platform with a wholesaling and distribution infrastructure.
  • Management of the entire supply chain, including product and financial flows, public tenders, and handling of medicine shortages.
  • Commercial compliance, ensuring promotional materials are validated and sales activities meet regulatory standards.

This team puts the approved drug onto the market and into the hands of patients.

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