Based on more than 20 years of experience, our main tools are a strategic approach, rapid service and clear communication on your projects. During this period, we have provided services to a big number of companies (leading multinational pharmaceutical companies and / or their local Benelux affiliates) with our in-house expertise in dealing with local requirements and regulations/interpretations in the fields of Regulatory Affairs and Pricing and Reimbursement.
Established since 1993
Farmaconsult has been established since 1993 by Kathleen De Vrieze, industrial-pharmacist, having many years of experience (since 1983) in Regulatory Affairs, first and predominantly in national registration procedures (Benelux) and since several years also in European procedures.
As most activities are realized by pharmacists, most experience has been gained in the redaction of chemical-pharmaceutical (variation) documentation and corresponding expert reports / summaries, in close cooperation with the applicants and with good contacts with the local Authorities.
European level experience
Farmaconsult also offers consultancy for storage- and distribution licences (GDP) and takes the necessary responsibility (acts as attorney) for foreign companies/registration-holders with a pharmaceutical activity in Belgium (local Information Manager and national QPPV).
On the European level experience has been gained as a partner in several European procedures (international network): mostly MRP- and DC-procedures and a growing number of central procedures for drugs for human and veterinary use, belonging to several therapeutic classes: peptide drugs, hormones, anti-inflammatory drugs, respiratory drugs, gastro-intestinal drugs, immunosuppressants, ...
For foreign companies active support is given by Farmaconsult acting as attorney towards the Belgian authorities + support for the redaction of the response documents during MRP / DP and by compilation of the administrative documents / files / translations / revision of mock-ups required by the competent authorities for finalisation of MRP- and DC-procedures for medicinal products (final registration approval on national level).
During the last years, a lot of experience was gained for compilation of price- and reimbursement applications, according to the current national (BE/LUX) guidelines.
Also national notification procedures for cosmetics, vitamin and nutrient products and medical devices are part of the services Farmaconsult can offer.
Partnerships
As regulatory experts, we are often asked to explain how European drug registration procedures function and why on earth they need to be so incomprehensible and complicated.
What we have learned over the years is that market access and regulatory projects require diligence and attention to detail to guide them through to completion. International regulatory projects do generate tremendous workload at certain predefined points and sometimes short time periods when a fast response is essential to attaining a licence quickly.
EuDRAcon
For international licensing procedures, we are in the position to refer to a European-wide network of specialist consultancies - EuDRAcon 
- and thereby can guarantee access to national knowledge and experts in different fields. Furthermore, a customised international team can be quickly assembled from this network.
Tarius
Farmaconsult is currently the Belgian partner for Tarius. Tarius is a Regulatory and Compliance regulations database offering value-added access to comprehensive compilations of reference documents from governments, agencies and international regulatory bodies as well as pharmaceutical experts unique national summaries
