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Registration / Notification 

We are able to meet your specific regulatory needs in the whole product regulatory lifecycle. Our key competitive advantages lie in Knowledge & Long-term experience, Tailored made services, Flexibility, Efficiency and Creativity.

We offer full registration and notification services in area of medicinal products, medical devices, cosmetics and food supplements. Based on long-term experience our team of experts has the knowledge and ability to help you during short consultation or deliver tailor-made solutions of the whole process.

Medicinal products

  • Dossier Compilation and pre-submission evaluation
  • Compilation eCTD files
  • Support in creating Module 1
  • Full management for CP, MRP, DCP and National procedures
  • Postmarketing maintenance
  • Regulatory Affairs support in Europe
  • Marketing Authorization Holder service
  • All the above-mentioned services are similar for veterinary products

Medical devices

  • Notification of manufacturer, distributor/medical devices
  • Compilation and evaluation of technical documentation
  • Mandatory requirements of labelling
  • Monitoring of EU /local legislation
  • Support for clinical trials

Cosmetics

  • Notification of distributor/manufacturer and notification of cosmetic products in the EU
  • CPNP database maintenance
  • Classification of cosmetic and borderline products according to the EU regulation 1223/2009/EC
  • Consultation and evaluation of product documentation, labelling
  • National requirements

Food supplements

  • National Notification of food supplements
  • Consultation and local legislative monitoring
  • Labelling requirement, checking, consultation
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