Depending on the individual situation and requirements, our role can range from the compilation and submission of the application to the data generation and preparation of modules 1, 2 and 3 of the licensing dossier. Especially with regard to drug licensing, our organisation proves to be of advantage in rapid decision-making and prompt action! Expert partnership can be offered for following activities:

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 authorisation 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 authorisation 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 authorisations (variations / renewals)
  • Translation services
  • Support for general Storage and Distribution Licences for medicinal products
  • Clinical Trial Applications to the Competent authorities
  • Pharmacovigilance support (acting as national QPPV)
  • 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

Farmaconsult also offers consultancy services and takes the necessary responsibility (acts as attorney) for foreign companies/registration-holders with a pharmaceutical activity in Belgium (storage- and distribution licenses - GDP).

Pricing and Reimbursement

Strategic advice, preparation of applications and support for BE/LUX.

  • Market access support
  • 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
  • Support for local contacts with local stakeholders - lobbying
  • Assessment of commercialisation issues
  • Discussion with involved authorities, governmental bodies

Knowledge of the procedures, expertise in the field and good, personal contacts with the competent authorities and with the local decision-makers is a must in this still field of national competence.