Offered services:
- Obtaining, maintaining and renewing the Production of active / Finished medicinal substances authorizations;
- Support In document and workflow management for the SIS code acquisition;
- Setting up and submission of the type IA, IB, II, Line Extension variations, AIC transfer practices and Renewals;
- Chemical-pharmaceutical documentation Setup (Common Technical Document (CTD) - Module 3) and related Expert / Quality Overall Summary report;
- Clinical Expert Summary (Module 2.4 and 2.5) development;
- Regulatory, Technical and Scientific documentation development for the drugs registration and changes in existing records;
- Due diligence and gap analysis;
- NTA file conversion for the registration in Nees or eCTD format: preliminary assessment, filling the corresponding forms and its publishing;
- Development and preparation of the Nees / eCTD format dossier;
- Audits at manufacturing sites of active ingredients (API) and finished products in Italy and abroad.
