what can we do for you

medicinal products

a glance of what we can offer...

  • Consulting in regulatory strategy for medicinal products (NP, MRP, DCP, CP), local and EU 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 and appropriate QMS);
  • 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 services and writing of SPC, patient leaflet and labeling;
  • Obtaining or updating licenses for import, wholesale, or export of medicinal products;
  • ....

supplements, cosmetics and other services

 

  • 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;
  • Advise on local practicalities and compliance with local regulations;
  • Regulatory training to your new employees or in-depth training to existing employees.

clinical trials

 

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

medical devices

Medical devices - the new EU Regulations !

  • Extensive knowledge of the new EU Regulations (Reg EU 2017/745 and 746);
  • 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 Benelux Competent Authorities;
  • Regulatory training to your new employees or in-depth training to existing employees.

questions - quotes

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