We offer you full service for the regulatory transition of your product from submission to registration. Drug registration is a lengthy, complicated and expensive process that requires highly experienced knowledge to ensure smooth and cost-effectiveness development as well as forward –looking approach to minimize unexpected delays.
A-Pharma expert team copes with all the related procedures such as:
- obtaining management and policy support
- review of enabling legislation and regulations
- identification of needs, definition of enabling objectives, and priorities establishing
- review of forms, procedures, and correspondence
- update of forms and certificates as required
- preparation of data and deciding how to handle data entry
- beginning of computerization
- negotiation with the State Institute for Drug Control
- application to the the State Institute for Drug Control
- eCTD
