Overview

G&L Healthcare Advisors was engaged by a small UK pharmaceutical company preparing to submit an EU Marketing Authorization Application (MAA) for an allergic rhinitis inhalation product.

Although the product had been approved in the US in 2006, it required significant updates for the EU submission, including revisions to non-clinical and clinical data to meet European Medicines Agency (EMA) standards.

Challenges

The client encountered several challenges in preparing for the EU submission:
Extensive document updates: The client needed significant updates to non-clinical and clinical data to meet current EMA requirements, including new efficacy data and post-marketing pharmacovigilance.
Limited in-house expertise: The client lacked internal regulatory expertise and required full regulatory and medical writing support to manage the EU Scientific Advice Meeting and MAA authoring.
Flexible resource allocation: The client needed a flexible medical writing team that could adjust their hours to match the varying demands of the project.

G&L’s Approach and Solution

G&L provided a virtual regulatory team to meet the client’s needs, including medical writing and regulatory strategy support. Key activities included:
Flexible team support: G&L provided a team of medical writers who could ramp up or down their hours as required throughout the project’s different stages
Article 8(3) route identification: G&L identified the Article 8(3) mixed marketing route as the most appropriate regulatory path for the product’s EU submission.
Comprehensive content development: G&L led the MAA content authoring and review, conducting a thorough literature search for new efficacy data and incorporating post-marketing pharmacovigilance data into the submission.

Impact and Outcomes

As a result of G&L’s support:
Successful Scientific Advice Meetings: The client had successful Scientific Advice Meetings with the EMA and submitted their MAA via the EU DCP process on schedule.
MAA approval progression: The client remains on track to obtain MAA approval for the allergic rhinitis inhalation product.
Cost-effective regulatory support: G&L’s flexible approach provided the client with cost-effective and efficient regulatory support tailored to their evolving needs.