Surviving the paperwork after clinical stage drug development

Surviving the paperwork after clinical stage drug development

Valérie Ryheul Posted 03 February 2020

A company that has all the money and research it needs, will not necessarily succeed in marketing their drug. Drug development is an extremely complex and lengthy process. It requires a collaboration of internal and external stakeholders and a lot of funding. The last hurdle before going to the market is the complex paperwork.

During preclinical research and clinical phases, companies need to be in constant communication with the regulatory authorities. This results in piles of applications at every step of the process. After successful ‘pivotal phase III’ studies, a company's drug is ready to go for an MAA (Marketing Authorization Application) submission.

The format of a dossier submission is a Common Technical Document (CTD). This is a selection of documents and data that tells the full story of how the product has been developed. It shows how well it ‘works’ based on safety and efficacy data. Post-approval commitments will also be included in the dossier. Once that CTD has been created, it will then be submitted to the health authorities. It is possible that they will ask further questions, additional data and/or meetings. Eventually they will decide whether approval for public marketing will be established or not.

Usually companies have their own very detailed internal timelines that fit into their corporate strategy, but also the health authorities have their own timetables of when a CTD should be submitted. Missing the (post-) submission deadline could have a disastrous effect on the business strategy.

The process of a regulatory submission is time-consuming and allows no room for error. The key to be successful is to find ways of streamlining the regulatory submission process and having a specialized project manager on board. Someone who understands the regulations and the obstacles, and who can translate the complexity into manageable timelines in order to submit on time. Because the development of a drug takes very long, people may only have had the opportunity to work on one, maybe two dossier submissions during their career.

At Modis we have experts who can create that extremely complex project management puzzle that is needed for a dossier submission. We can help and give advice how the structure of a CDT should look like, how a cross-departmental plan can be built and maintained and how to interact and communicate with multiple stakeholders.

Valérie Ryheul
Project Manager Life Sciences

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