Client Background:

The manufacturer is one of the global producers of diabetes medicine which is intended to treat diabetic patients.

Client Problem:

The manufacturer needed assistance in CTD preparation as they don’t have any their internal team to prepare the CTD as per ICH requirements.

ND Global Solution & Approach:

ND Global developed the Submission ready documents (CTD) with more than 95% quality and, organized review. The customer received a thorough review from us and consultation support to close any gaps.

Project Achievements:

Based on their positive experience, the customer extended the scope of work to seek support for future products.

Project Outcomes:

Health Canada accepted them without making any observations.