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EMA/National Agencies Regulatory Strategy and Gap Analysis

Best-In-Class Strategy for Every Step of the Submission Process

Every regulatory submission has a number of moving parts, each one interconnected. Changes in one piece can have a far-reaching impact through the rest of your submission package. A misstep in one area can create a domino effect through the entire process, putting your development and go-to-market timelines at risk.

Having a clearly defined regulatory strategy is one of the most crucial components of success. Every step of your pre-authorization preparations — from the study design and filing strategy, to data analysis and dossier writing, and through regulatory operations and satisfying post-authorization commitments — depends on thoughtful planning and anticipation of what is required by which authorities and when.

At ProPharma Group, we have a deep understanding of the regulatory landscape in Europe and know what it takes to achieve successful marketing authorization. We use a science-focused approach to help you develop a plan, assess it to examine current performance with desired outcomes, and identify and fill in any gaps between the information you have and what is needed for a successful submission. As an extension of your team, we ensure you have a comprehensive regulatory strategy in place that helps you meet every objective before, during, and after marketing authorization, and supports your ultimate objective of improving patient health and safety.

Scientific Experts With Regulatory Insight

Our experts are scientists, first and foremost, with extensive backgrounds in global regulatory affairs, pharmaceutical development, and academia. We understand that novel application of science is often required to successfully navigate global approvals. Our team knows how to leverage current data or seek new data to meet your objectives.

Successfully working through each stage of submission requires a thorough understanding of regulatory nuances and the ability to match your submission package with the distinct expectations of each committee. Through our 30+ years of regulatory experience in the European Union (EU) and European Economic Area (EEA) we’ve formed relationships with key contacts on multiple committees within the European Medicines Agency (EMA) and national agencies, giving us critical insights into what is expected to conduct successful interactions with the correct authorities.

Regardless of where you’re located, what Agency you’re seeking approval from, and where you are in the product lifecycle, our experts can help ensure you have the right regulatory strategy in place. Whether you’re in the early stages of development, commercialization of your product, or anywhere in between, our team can help set you up for success by conducting a gap analysis and developing and implementing an appropriate regulatory strategy. We know how to put it all together into a comprehensive document that maps out key submission components in the right sequence of events and can partner with you through every step, including:

  • Gap analysis of existing or new dossiers
  • Drafting and coordinating the Regulatory Product Development Plan (RPDP), covering all aspects of development
  • Advice and planning of regulatory deliverables and timelines
  • Advice on, or serving as liaison for, interactions with the Health Authority (HA)
  • Advice on, or leading the development of, the filing strategy (ie, legal basis for the application, choice of procedure, etc.)

Are you in the process of developing an Agency-regulated drug product? Do you have Agency comments and want a second opinion on how to respond? Maybe you’ve submitted your application and are waiting for Agency feedback, or are in the commercialization phase. Regardless of where you are in the process, having a detailed strategy in place is the key to regulatory success across with both the EMA and local national agencies, as well as with the Food and Drug Administration (FDA) in the United States.

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