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
