Regulatory affairs BENELUX

• Preparation of documentation
  We are specialized in the writing of chemical/-pharmaceutical documentation and expert reports, including laboratory services if necessary. We analyze and complete provided documentation.
  Toxicological, pharmacological, and clinical documentation can be provided.
  We write and translate SPC, leaflets, and labelling and prepare all local documents as required.
  We compile documentation according to e-submission guidelines.
• Marketing authorisation
  We advise, assist or take care on your behalf, all applications, variations, updates, and renewals of marketing authorisations through national, mutual recognition, or decentralised procedures for NCEs as well as bibliographic and generic medicinal products (human and veterinary).
  We do the follow-up of ongoing procedures and provide all translations necessary for the finalization of the procedures.
• Training and assistance
  We can provide training on all regulatory issues to new personnel or assist your existing regulatory affairs department with all short-, medium-, and long-term projects.

Regulatory compliance and scientific service

• We act as your local responsible person for pharmacovigilance.
• We act as your local responsible person for publicity and information.
• We provide clinical and pharmaceutical information as well as documentation and advice on local regulations.
• We assist your company in obtaining or updating of your licence for import, wholesale, or export of medicinal products.

Good distribution practices

Vandenbussche Farma Service has extensive experience in the development, implementation, maintenance, and update of quality systems for good distribution practices (GDP).

Pricing of medicinal products within the BENELUX

Vandenbussche Farma Service advises you on local pricing legislation and pricing possibilities within the Benelux. We compile price application and price increase dossiers and take care of all submissions and follow-up (both non-reimbursable and reimbursable medicinal products).

Reimbursement of medicinal products within the BENELUX

We advise on local reimbursement systems.
We assist, compile, and submit reimbursement application dossiers according to local requirements and do the follow-up of ongoing procedures.