Regulatory affairs
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 (module 1 tot 3)
  • Preparation of expert / summary reports on the chemical-pharmaceutical documentation
  • 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
  • Clinical Trial Applications to the Competent authorities
  • Pharmacovigilance support (acting as Local contact Person for PharmacoVigilance - LPPV)
  • Critical review of advertising and promotional materials (local responsible person - local Information Manager)
  • Preparation and submission of notification files for nutrients / cosmetics / medical devices
  • Liaison with nationally competent regulatory authorities
Pricing and Reimbursement
Strategic advice, preparation of applications and support for BE/LUX.
  • Market access support (HTA)
  • Strategic advice on market access, application strategy and procedures
  • Preparation of price and reimbursement applications for pharmaceuticals in Belgium and Luxemburg
  • Assessment of price level and reimbursement modalities within the Health Care Environment of Belgium and Luxemburg.
  • Follow-up of applications on a daily base with the local authorities, including revisions, contract procedures
  • Support for local contacts with involved stakeholders - lobbying
  • Assessment of commercialisation issues
  • Discussion with involved authorities, governmental bodies