Gap Analysis
A regulatory review process that identifies data gaps in the technical documentation required for preparing the dossier & the application before applying for regulatory approval, we start where others stop, knowing that international market success does require local expert knowledge, drive and network.
We offers comprehensive gap analyses services including review of customers’ facility and product related -specs, labels and other technical documentation related to:
- Facility Registration
- Initial Submission
- Dossier Extension of Registered Products,
- Registered Dossier of Legacy Drug products
- Lifecycle Management