Regulatory Affairs

Excelya>Capabilities>Regulatory Affairs

Our Regulatory Affairs department provides a clear path to regulatory approval by ensuring confident, accurate and timely document submissions. Our regulatory team has up to 20 years of experience across all therapeutic area, phases and industries. We support marketing authorisation application across the product lifecycle, including market access and promotional material compliance.

We leverage flexibility, experience in multidisciplinary projects, excellent relationships with health authorities and deep knowledge of the regulatory environment to ensure that your submission is ready for review and timely conclusion.

Excelya's scope of action

What we deliver

Our clinical trial services take you from initiation to follow-up to completion. They include:

  • Development: Core documentation regulatory review & submission strategy
  • Submission/review: EU planning, EU CA/EC submission, answer to CA/EC questions
  • Activation: Public registry registration, FVLP
  • Conduct: Amendment follow-up, public registry update, completion

Our marketing authoriation and post-marketing authorisation services include:

  • Μarketing Authorisation Applications for medicinal products (DCP/MRP/National Procedures)
  • Local activities following Centralised Procedures
  • Maintenance of the Marketing Authorisations, Variations and Renewals
  • Transfers of Marketing Authorisations
  • High quality translations of the Summaries of Product Characteristics, Labeling and Patient Leaflet
  • Effective collaboration with the authorities and follow-up of submissions, to ensure timely conclusion of the procedures
  • Publishing in eCTD
  • Pricing and Reimbursement applications and consultancy
  • Regulatory review of artworks/packaging material
  • Regulatory review of promotional material
  • Regulatory Intelligence
  • Consultancy services on local regulatory provisions and requirements.
  • Notifications/Registrations and consultancy services for medical devices, food supplements, cosmetics and biocides
  • Training in Regulatory Affairs
Depth and breadth of experience

Multiple therapeutic areas, phases and industries

We have experience with clinical studies across therapeutic areas, phases and industries:

  • Phase I to IV, observational studies
  • Oncology, Infectious disease, CNS, Hormonal Disease, Metabolic Disease, Veterinary
  • Pharmaceutical, nutraceutical, devices, cosmeceutical, nutrition, biotech