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14 August 2018

Compressing Timelines Toward Regulatory Submissions Without Sacrificing Quality

Written by Liz Bloss

 

Problem

A pharmaceutical company needed to submit a New Drug Application (NDA) and a Marketing Authorisation Application (MAA) under extremely tight timelines. Senior leadership had promised a highly aggressive date for product approval and launch.

Solution

Expert advice to the company’s cross-functional team charged with improving the complex submission preparation, decision making, and communication process led to a high-quality content NDA/MAA submission within compressed timelines. While an NDA/MAA submission is a key milestone in the development life cycle of a regulatory approval, the time between submission and approval is also vital to a successful outcome. A close interface with the project planning team provided insights during the submission process on how to address questions and comments from the competent authorities (FDA and EMA) during the NDA and MAA review.

Influence on creation of the cross-functional team, comprised of SMEs in various locations globally, delineated clear roles and responsibilities in preparing the submission, and facilitated interfacing with them on an ongoing basis throughout the preparation leading to the submissions and during the FDA and EMA review. Review and refinement of each team member’s role and responsibilities avoided overlaps or gaps and clarified activities for all team members. Taking the time to refine this aspect in the beginning and building in periodic checks and balances saved time in the end. 

Creating clear communication channels within the cross-functional team and between the team and senior leadership allowed the team to remain nimble and focused on decision-driven outcomes.

Outcome

This type of communication path and process contributed to the creation of a high-quality dossier within a highly compressed timeline. Using this method significantly reduce the standard review time from 12 months to 9.5 months.

Since each team member and SME played an important role in preparing documents for the regulatory authorities, these documents required a clear integrated message within the regulatory framework using a communication style that the FDA and EMA are accustomed to.  

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