If you are looking for a regulatory affairs professional willing to go the extra mile to satisfy your needs for high quality services, on time and within budget, then Pharma-Contact is your ideal partner for Benelux regulatory affairs... because we love what we are doing.
Pharma-Contact offers a comprehensive package of regulatory services for the pharmaceutical and food industry. Whether your project is conducted locally or in a complex international environment, we are passionate about the job!
Every day, every project, we strive to make a difference in what we are doing.
Pharma-Contact is located near Ghent and owned by Isabelle Geeraert, Pharmacist. She graduated at the Catholic University of Leuven in 1994 and specialised in Hospital Pharmacy in 1995.
After she graduated, Isabelle moved to Australia for profes-sional reasons (marketing area), and from there to Switzerland, where she first got into contact with regulatory affairs. Fascinated by this field, and driven by the wish to share her enthusiasm, she decided to continue as a freelance regulatory affairs professional after returning to Belgium in 2006.
Her experience in different fields as marketing, manufacturing and regulatory affairs, and her extensive knowledge of French, English and German provide an excellent basis to estimate and meet the needs of the pharmaceutical and food industry.
References are available on request.
Food supplements, Cosmetics, Medical devices and other services
Consulting in regulatory strategy for medicinal products (NP, MRP, DCP, CP);
Evaluation, preparation and submission of Marketing Authorisation Applications, variations and other applications (5 year renewal, PSUR,...) to local Benelux Competent Authorities, all following latest e-submission standards;
Traditional and well-established herbal medicinal products (Directive 2004/24/EC);
Review of advertising and promotional material;
In house translation services and writing of SPC, patient leaflet and labeling;
Readability testing of patient information leaflets;
Interactions with national competent authorities;
Obtaining or updating licenses for import, wholesale, or export of medicinal products.
Notification of food supplements to Benelux Competent Authorities;
Extensive knowledge of impact of the Nutrition and Health claims regulation (EC) No 1924/2006; Review of promotional material;
Strategic input on herbal food supplements;
Notification of cosmetics and medical devices to Benelux Competent Authorities;
Obtain distribution licenses for medical devices;
Advise on local practicalities and compliance with local regulations;
Regulatory training to your new employees or in-depth training to existing employees.
Submission of clinical trial applications to Benelux Competent Authorities;
Project management and follow-up of clinical trials, worldwide;
We focus on what we can do best: increase your efficiency by offering customized yet flexible services.
To achieve this, we rely on:Our passion for what we do; Excellent organizational skills;Regulatory know-how and hands-on experience;International network of industry experts, university professionals, consultants and regulatory organizations.
bvba Pharma-Contact, Artemeersstraat 11, B-9880 Poeke, T +32 496 85 87 49, firstname.lastname@example.org
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