The Slovenian company "FarReg" provides assistance to foreign and local companies in the pharmaceutical issues in field of regulatory, pharmacovigilance, pricing&reimbursement, marketing support and distribution.
FarReg advises its clients on product registration and current or anticipated regulatory trends and/or hurdles. We help our clients to avoid potential administrative errors and pitfalls that can cost significant time and money.
We offer to our clients:
- The complete service list for the registration of the pharmaceutical products from preparation of the dossier (in accordance with the requirements of legislation) to the registration certificate (marketing authorization) obtain, in accordance with legislation of Slovenia and even more: preliminary and selective control of the registered pharmaceutical products, implementing changes to the registration certificate of the pharmaceutical products
- Cooperation with the Competent Authority (Agency for medicinal products and medical devices - JAZMP) in the field of registration of pharmaceutical products.
- Translation of the medical documentation.
- High-quality pharmacovigilance services. We ensure the fulfilment of marketing authorization holder´s obligations in the field of pharmacovigilance in relation to the Competent Authority as well as to the client´s headquarters, including representing the client as a local contact for pharmacovigilance and handling of adverse event reports. Furthermore, we offer our assistance in registering your company in Eudravigilance database and electronic adverse event reporting.
- Forming and reporting of the maximum allowed price (NDC) and in case of necessity preparing the application for the approval of extraordinary higher allowed price (IVDC) to the JAZMP.
- Preparation of the reimbursement applications for the competent authority (Health Insurance Institute of Slovenia - ZZZS).
Within all of above mentioned services, FarReg can also provide the support and assistance with documentation preparation, and during the whole procedure at the relevant competent authority.
We will be glad to see you among our regular clients.
WE HELP YOU SAVE TIME & EFFORT TO GET YOUR PRODUCT REGISTERED!!
We can fully and individually adapt ourselves to the client's needs.