We are able to meet your specific regulatory needs in the whole product regulatory lifecycle. Our key competitive advantages lie in the 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.

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Medicinal products

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• 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

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• Notification of manufacturer/distributor/importer of Medical Devices

• Evaluation and compilation of technical documentation

• Mandatory legislative requirements for labelling of medical devices

• Monitoring of EU /local legislation

• Support and performing of clinical trials​

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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 

• Consultation and evaluation of product documentation, labelling

• National requirements
   

Food supplements

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• National Notification of food supplements

• Consultation and local legislative monitoring

• Labelling requirement, checking, consultation

• Translation