• Consulting in regulatory strategy for submission of medicinal products (NP, MRP, DCP, CP) to local Benelux and EU Competent authorities;
• Evaluation, preparation and submission of Marketing Authorisation Applications, variations and other applications (renewals, PSUR,...) to local Benelux and EU Competent Authorities, all following latest e-submission standards;
• Traditional and well-established herbal medicinal products (Directive 2004/24/EC);
• Interactions with national competent authorities;
• Pharmacovigilance services (Local Qualified Person);
• Review of advertising and promotional material (RIP nr 849);
• Set-up and maintenance of a QMS for the distribution of medicinal products (GDP conform);
• In-house translation and writing services for SPC, patient leaflets and labelling;
• Obtaining or updating licenses for import, wholesale or export of medicinal products;
• ....

• Notification of food supplements to Benelux Competent Authorities;
• Extensive knowledge of EU Food law (Nutrition and Health Claims Regulation, Food Information to Consumers (FIC), Additives Regulation...);
• Review of promotional material;
• Advice on local practicalities and compliance with local regulations;
• Regulatory training for new employees or in-depth training for existing employees.

• Submission of clinical applications to Benelux Competent Authorities;
• Project management and follow-up of clinical trials, worldwide;
• Pharmacovigilance support.

Thanks to our extensive knowledge of the new EU Regulations for medical devices (Reg EU 2017/745 and 746) we can help you with...

• Writing and compiling Technical Documentation for medical device dossiers;
• Set-up and maintenance of a QMS for the distribution of Medical Devices;
• Advice on local practicalities and compliance with local regulations;
• Review of promotional material;
• Notification of medical devices to the Benelux Competent Authorities;
• Regulatory training for new employees or in-depth training for existing employees.