Client Background:

The client was a pharma manufacturer who produces medicines in different therapeutic areas such as Ophthalmology, Pulmonology, and Dermatology.

Problem:

They were facing issues in preparing the CSR and needed assistance in drafting the responses to NB if they received any.

ND Global Solution & Approach:

ND Global developed CSR on CTR -compliant templates in accordance with the European medicine agency. The customer received a thorough Gap Assessment from us and consultation support to close any gaps in their prior CSR for compliance with CTR.

Project Achievements:

Based on their positive experience, the customer extended the scope of work to seek support for MDR-compliant documentation for their devices.

Project Outcomes:

The EMA accepted the without making any observations.