Overview

A large pharmaceutical company in Bangladesh specializing in generic products required regulatory support for their UK and EU Marketing Authorization Applications (MAAs).

The client needed assistance with the authoring and publishing of Modules 1-5 of the MAAs, as well as clinical and non-clinical content development to meet UK and EU regulatory standards.

Challenges

The client faced the following challenges in the submission process:
Complex submission requirements: The client’s products included value-added, high-technology dosage forms, which required detailed Module 2 summaries and overviews, as well as full clinical and non-clinical sign-off for Modules 4 and 5.
Coordination across multiple markets: The client required regulatory submissions for both the UK and EU, which demanded careful coordination and alignment with the distinct requirements of each market.
Time-sensitive submissions: The client needed to submit multiple MAAs within strict timelines to ensure product launches remained on schedule.

G&L’s Approach and Solution

G&L provided a team of experienced regulatory experts to guide the client through the submission process. Key activities included:
Regulatory and medical writing support: G&L assembled a team of regulatory, Chemistry, Manufacturing and Controls (CMC), clinical, non-clinical, and publishing consultants to support the authoring and submission of Modules 1-5 for the UK and EU MAAs.
Clinical and non-clinical sign-off: G&L’s clinical and non-clinical experts authored the necessary summaries and overviews for Module 2 and provided sign-off for Modules 4 and 5.
Publishing and submission: G&L ensured that all modules were properly authored and published before submission to the relevant authorities, ensuring compliance with UK and EU requirements.

Impact and Outcomes

As a result of G&L’s involvement:
Successful submissions: The client successfully submitted their MAAs in accordance with the required timelines.
Product approvals: The client received approval for two of their products, with a third MAA on track for approval.
Ongoing regulatory support: Following this success, the client requested ongoing regulatory support from G&L for future submissions.