Pipetovací Vzorky a zkumavce

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