Peri-Approval Services

Be Prepared Before the First Clock Stop

From the time you submit your marketing authorization application (MAA) to the European Medicines Agency (EMA) to the time you obtain approval, there is always an enormous amount of work to be done. Understanding the timetable for assessment and having the right resources in place will ensure you meet every requirement and hit every deadline.

Before you receive the list of questions (LoQ) from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on day 120, it’s crucial to have an effective project management plan in place to maximize the speed of work, efficiency, and accuracy of deliverables. Knowing what data is needed, how and where to obtain it, and how to prepare responses to the Agency’s questions can ensure the success of your approval.

During the peri-approval process, the decisions you make dictate the path for your product over the next few years and affect your approach for marketing and commercialization. Our experts at ProPharma Group have a deep understanding of the science behind your product and extensive experience with the EMA approval process. We can help you develop a program, conduct the work, craft responses, and publish and submit the data. As a true extension of your team, we understand your obligations and requirements and keep you on track to help you achieve the desired authorization.

A Plan for Unpredictable Requirements

While the assessment of an MAA for a new medicine takes up to 210 “active” days, at day 120, there is a pause in the EMA work (a “clock stop”) when you are required to provide the EMA with responses to their questions relating to your original submission. These questions take many forms and can include requests for:

  • Additional statistical analyses
  • Label/packaging updates
  • Revised patient-user testing
  • Negotiations for post-approval communications (PASS)
  • Chemistry, manufacturing, and controls (CMC) data
  • Updates to your risk management plan (RMP)
  • Requests for post-authorization efficacy or safety studies

Usually, you have up to three months to respond to these questions, and then the EMA starts their review again, with a further clock stop at day 180 to address any outstanding queries.

Peri-approval requirements can often be unpredictable and complicated and may create challenges for your internal resources. Our experts have vast experience with MAA assessments for a wide range of products. We have worked with companies of all sizes with varying levels of experience and resources and have a thorough understanding of the timing and planning demands for response submissions. Our team of science-first experts has extensive regulatory expertise on both global and local levels and can partner with you to navigate the process and gain approval for your product as quickly and efficiently as possible.

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