NextraResearch is qualified to manage regulatory activities at EMA, by national regulatory authorities and notified bodies in EU countries, the Drug Agency and the Ministry of Health in Italy Procurement Service available to act on behalf of the MaHs, manufacturers of the Medical devices.
Medicinal products for human and veterinary use:
- Scientific Advice (at the Ema) and Parallel Scientific Advice (by the FDA)
- Editiong of the CTD dossier its preparation in electronic version (eCTD: NeeS, VNeeS, eSubmission).
- Managements of the Products: variations, renewals and transfers.
- As Applicant of the behlaf of the MaH: National and European registration procedures (National, MRP, DCP and Centralized).
- Test for readability leaflet (Readability Testing Package Leaflet)
- In Italy: sworn translation into German of leaflets and labels and insertion of network Unifarm (bilingualism)
- Consulting, preparation of price dossiers, HTA reports and negotiation
- Transfers of the MaH.
- Strategic advice for studies of PK / Bioequivalence of Phase I and next conducting Clinical Trials
- Support for the search for partners to develop chemical and pharmaceutical tests analytical, stability, etc.
- Registration of generic specialty of expired patents through contacts with companies willing to sell the the Ma
- Orphan Drug
- CE certification
- Risk analysis, Ornamental Technical File, Notification on the national portal
- Staging PIF (Product Information File) and notify the European portal
Nutraceuticals (Dietary Supplements and Food for special medical purposes):
- Developing formulations, labeling preparation, notification to the national Ministry of Health
- Notification of Raw Materials and registration of additives.
- Development and notification of feed, medicated feed, feed exports to Russia.
- In the EU countries: registration of trademarks and patents, certificates of free sale.
- In Italy: retirement of decisions and administrative acts at the Ministry of Health and AIFA.
NextraResearch is a micro enterprise, qualified by the SME Register - European Medicine Agency (EMA)