Regulatory Affairs

Svelte® 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