Our expertise

Regulatory affairs & Vigilance

Our experts guarantee the compliance of your healthcare products while enhancing patient safety to accelerate the market access of your innovations. We ensure rigorous vigilance and strategic monitoring throughout your products’ entire lifecycle.

Pictogramme AR et vigilances 2026

Presentation of the divison

From development strategy to post-marketing, we secure the compliance and safety of your pharmaceuticals, medical devices, and cosmetics. Our regulatory activities cover the entire product lifecycle, from technical dossier writing and submissions to securing MAAs, CE marking, and advertising compliance. Concurrently, our expertise in Vigilance ensures continuous monitoring. This synergy protects your healthcare assets and optimizes their market sustainability in the face of the strictest regulatory requirements

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Our expertise – Regulatory affairs

Advertising Compliance Officer
CMC Technical Regulatory Writing Expert
Submissions and Registration Specialist
Global Regulatory Affairs Consultant

FULL PRODUCT LIFECYCLE SUPPORT
Regulatory Affairs

Affaires règlementaires EN

Our expertise – Vigilance & Safety

PV Case Processing Manager
Cosmetovigilance Officer / Toxicologist
Safety Database Administrator
Signal Detection and Risk Management Expert
Periodic Safety Report Writer (Safety Report Lead)
PV Auditor (QA / PV)
Qualified Person for Pharmacovigilance (EU-QPPV)

FULL PRODUCT LIFECYCLE SUPPORT
Vigilance

Vigilance EN

Therapeutic Areas

  • Pharmaceuticals
  • Biotech
  • Medical Devices
  • Healthcare Facilities
  • Cosmetics
  • Nutrition
  • Animal Health

Industries

  • Oncology & Hematology
  • Vaccines
  • Rare Diseases
  • Pulmonology
  • Immunology
  • Dermatology
  • Neuroscience
  • Cardio-metabolism
  • Allergology
  • Ophthalmology

Contact
us

EN – Formulaire de contact