Regulatory Affairs

SvelteĀ® scientific offers expert support in Regulatory Affairs, particularly in relation to the following areas:

  • Comprehensive management of regulatory projects
  • Preparation, submission and implementation of European regulatory procedures (MRP, DCP, national)
  • Life Cycle Management: Preparation and implementation of Variations and Renewals
  • Up-dates and maintenance of national and international registration dossiers
  • Electronic processing of documents relevant to drug approval (eCTD, NeeS)
  • Communication and coordination with regulatory authorities and cooperation partners
  • Communication and coordination with internal departments and external service providers