SciencePharma offers its expertise in:
- choosing the appropriate procedure,
- deciding on the type of application
- deciding on the form and content of the dossier,
-
preparing all or part of the registration documentation according to the requirements
of specific registration agencies, including:- declarations templates
- proper justification for types of application (Module1.5.1, 1.5.2),
- expert reports on Environmental Risk Assessment (Module 1.6),
- Pharmacovigilance (Module 1.8.1, 1.8.2)
- Clinical Overview and Clinical Summary (Module 2.5, 2.7) together with the prepartion of Module 5,
-
Non-clinical Overview and Non-clinical Written and Tabulated Summary
(Module 2.4, 2.6) together with the preparation of Module 4, - Full Module 3 together with the Quality Overall Summary,
- preparing/evaluating/translating of the Summary of Medicinal Product, Patient Information Leaflet and Labeling,
- preparing the documentation in eCTD format
- evaluating the dossier indicating the deficiencies
