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.
Many stakeholders are involved when important themes come up in the field of medicines and related products. The Pharma world has to deal with a continuously growing number of regulations, directives and requirements imposed by the administrative and regulatory environment. Competent authorities as well as pharmaceutical companies focus on bringing new and innovative medicinal products more rapidly to the patient. In order to make this happen, a focused and transparent market access strategy is a must.
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 Local contact Person for PharmacoVigilance - LPPV).
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 incl. HTA (pharmaco_economics). This is applicable to innovative, orphan drugs as well to medicines with a well-established use (incl. generics, copies, hybrids,…).
Also national notification procedures for cosmetics, vitamin and nutrient products and medical devices and revision/advice on advertising materials/campaigns are part of the services Farmaconsult can offer.
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.
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.