VeirupConsult

Regulatory Affairs

• Preparation of dossiers for submission of new applications for Marketing Authorisation. Contact to the Danish Medicines Agency or other relevant national Authorities.
• Maintenance of existing applications e.g. preparation and submission of variations- and renewal-applications.
• Coordination/preparation/review of documentation/reports according to current guidelines in cooperation with the company, project groups,  specialists and Authorities.
• Surveillance of pharmaceutical guidelines.
• Preparation of PILs and Summary of Products` Characteristics according to guidelines and in cooperation with experts.
• Preparation of labelling, translation and review according to national requirements.
• Review of marketing/promotion material, brochures etc. (In Denmark according to www.NSL.dk (The Danish Legal Board of Self-Regulation concerning Pharmaceuticals).
• Drug Master Files compilation or preparation of Certificate of Suitability`s for the active substance. 
• Temporary assistance for employee or manager.
• Ad hoc tasks.