Regulatory affairs for medicines for human use
Regulatory submissions and life cycle maintenance, post-approval, promotional review and approval.
  • GDP consultancy - local storage and distribution licence
  • Determination of regulatory and legal status
  • Determination of regulatory strategy for planning, manufacturing, preclinical and clinical development
  • Document preparation including marketing authorization applications for medicinal products (mod. 1-3)
  • Submission and management through to approval of marketing authorization applications via the EU, Mutual Recognition, Decentralised or National Procedures
  • Follow-up of applications including support for responding to deficiency letters from local authorities
  • Maintenance of existing marketing authorizations (variations/renewals/readability testing/Sunset Clause)
  • Translation services
  • Support for general Storage and Distribution Licenses for medicinal products / medical devices
  • Pharmacovigilance support (acting as Local contact Person for PharmacoVigilance - LPPV)
  • Critical review of advertising and promotional materials (local responsible person - local Information Manager)
  • Liaison with national competent regulatory authorities