Copyright 2008. The United States Pharmacopeial Convention. Reprinted with permission. All rights reserved
Preparation of registration dossiers:
- Compilation of registration documents according Notice to Applicants und Common Technical Document Standard
- Preparation of chemical- pharmaceutical Dossiers (CMC, Part II), basing on raw data.
- Drug Master File: Handling of EU Drug Master Files and US Drug Master Files
- Submission of documentation to EDQM for receipt of CEP
- Preparation of Technical Information Packages
- Handling of Letter of Access and further regulatory statements
Management of registration procedures:
- Assurance, that, all information provided in registration application and registration documents are consistent with actual guidelines and that all documents are going to be prepared in predetermined time-frames.
- Handling of deficiencies in technical matters as well as in form and content.
- Competent personal contact during all stages of validation and registration.
