We provide the services and professional consultancy related to registrations of human medicinal products (DCP/MRP and national registrations) in accordance with Act on medicinal products and medical devices:
- Authorized contact person of the holder at the State Institute for Drug Control (SIDC)
- Cooperation in the preparation of an administrative part of the registration dossier (Module 1)
- Payment instructions (eKolok)
- Submission of the eCTD sequences through the CESP portal
- Translation of the texts, assessment reports and Product Information in accordance with QRD templates
- Proofreading of the graphic designs of the packaging and leaflets in Slovak language (mock-ups)
- Cooperation in post-registration activities (renewals, transfers of registrations, variations)
- Advisory, consulting on post-authorization obligations of the MA holder (notifications of the first launch of the product on the market, suspensions and resumption of supplies, Sunset Clause, ,…)
- Local support for centrally registered medicinal products (texts, artworks, notifications)
- Monitoring of the national legislation and providing of information on the changes thereof (Regulatory Intelligence)
Interested in our services?
We are happy to answer any questions you may have.
pharmin@pharmin.skWhere to find us
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