ADgConsultancy

Services

From registration file to reimbursed product

Advice and execution across the regulatory and market access life cycle of human drugs, medical devices and related products.

Registration of human drugs

Professional advice for national and all EU procedures

  • Registration strategy
  • Contacts with the Belgian agency
  • Co-ordination between company and competent authorities
  • National and European legislation, followed up on demand

Support for preparation and follow up of

  • Registration files of your drugs
  • Renewals of registration
  • Variations on current registrations

Also

  • Training on registration of drugs
  • Contacts with opinion leaders, competent authorities and other stakeholders

Pricing

Professional advice

  • The best strategy for price setting
  • On procedures in the Benelux

Support for files

  • Preparation, writing and follow up of pricing files
  • For OTC drugs as well as drugs on prescription
  • In conformity with the current legislation

Follow up

  • Follow up of pricing files at the authorities
  • Contacts with competent authorities and other stakeholders

Reimbursement

Professional advice

  • Positioning of the drug in an existing class of drugs
  • The best reimbursement modalities
  • National legislation, training on procedures and follow up

Support for preparation and follow up of

  • Reimbursement files, including scientific motivation and answers during the procedure
  • Files for change of currently reimbursed products
  • Revision files

Various

  • Preparation of pre-submission meetings and hearings
  • Organisation of advisory boards
  • Contacts with file managers and experts at RIZIV/INAMI

Market access

Professional advice

  • Integration of the market access concept in your commercial launch plans
  • Drug evaluation plans
  • How to position your brand and gain or retain market access
  • Stakeholder involvement, impact and evaluation of product benefits

Contacts

  • Opinion leaders
  • Competent authorities
  • Other stakeholders

Production & distribution

Qualified Person (QP)

  • For production and distribution
  • Managed by recognised industrial pharmacist, registration number 1359

Advice for authorisations

  • Manufacturing authorisations and derogations
  • Distribution authorisations and authorisations for hormonal substances
  • Export declarations, GMP certificates, psychotropic drugs

Release of drugs

  • Preparation and revision of artworks
  • Administrative release for Belgium

Pharmacovigilance

National responsible person

  • Managed by a national responsible person pharmacovigilance, registration number P551
  • Advice on the composition and organisation of a detailed quality model to follow up pharmacovigilance

Information & publicity

Recognised responsible person (RD April 1995), registration number 501

  • Preparation and follow up of visa files for OTC drugs
  • Preparation and correction of visual aids for reps in conformity with national legislation
  • Review of the content of prescription books for physicians
  • Training, Mdeon files and advice on deontological rules