We assume all regulatory activities for your successful variation application. This includes:
- Evaluation of the feasibility and classification of the change according to the current guidelines;
- Preparation of the entire Module 1 including the electronic application form;
- Revision of the product information (Summary of Product Characteristics (SmPC), patient information leaflet (PIL) and labeling);
- Preparation of the Quality Overall Summary or Quality Expert Statement (Module 2.3);
- Preparation or revision of all Module 3 documents according to current guidelines;
- Compilation of the variation documentation;
- Submission of the variation to the competent authorities, e.g. via CESP;
- Answering deficiency letters;
- Communication with the competent authorities.
Company Core Data Sheets (CCDS) / Company Core Safety Information (CCSI)
- Comparative analysis of the nationally approved product information (Summary of Product Characteristics (SmPC), patient information leaflet (PIL)) and identification of discrepancies;
- Compilation of the source documentation as proof regarding the individual statements in the product information;
- Based upon the source documentation, preparation of the Company Core Data Sheet (CCDS; reference document providing information on the safety, indications, dosage and pharmacology to be implemented in the national product information) and Company Core Safety Information (CCSI; reference document with drug product safety information to be implemented in all countries);
- Preparation and submission of national variations in order to harmonize the national product information.
Renewal of marketing authorizations
We undertake all regulatory activities for your renewal application. This includes:
- Preparation of the entire Module 1 including electronic application form, CPP, QP declaration, etc.;
- Revision of the product information;
- Preparation of the Addendum to the Quality Overall Summary (Module 2.3);
- Compilation of documentation according to CTD format;
- Submission of the renewal application to the competent authority, e.g. via CESP;
- Communication with the competent authorities;
- Answering deficiency letters.
Transfer of dossiers in obsolete formats (e.g. NtA format) to CTD format
We would be happy to transfer your Quality documentation which is, for example, written in the Notice to Applicants (NtA) format to the Common Technical Document (CTD) format. If desired and in addition to the formal transfer of the approved dossier, we could check the content for compliance with the current guidelines and prepare missing documents, if applicable.