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Regulatory Operations

Ensure A Smooth Application Process and Reduce the Time to Market

After conducting clinical studies and obtaining necessary data, the next step is to prepare for submission of the marketing authorization application (MAA) by compiling the dossier and performing a gap analysis to ensure that all regulatory requirements are fulfilled. Any national requirements must also be adhered to, and the dossier can then be published and submitted to the relevant authorities.

The right strategy and knowledge are critical to determining which of the European Union (EU)/European Economic Area (EEA) filing procedures are applicable or preferred. In the assessment process, it is important to know the timelines and have a close dialogue with the health authorities. With successful dossier preparation and efficient submission and procedural management, you will avoid unnecessary delays and have a faster time to market for your product.

After approval of your initial application, you need to remain compliant with all regulatory requirements (eg, commitments, variations, renewals) to keep the product on the market. A strategic approach to lifecycle management is also valuable in maximizing the potential of the product (eg, line extension and additional indications).

At ProPharma Group, our regulatory experts are scientists with a deep understanding of the intricacies of regulatory operations. As a single-source provider of regulatory affairs, compliance, pharmacovigilance, and medical information services, we can help you meet every requirement.

Your Partner Through Every Step of the Process

We serve as a true extension of your team and help you with every aspect of your application, from pre-authorization through commercialization. Our regulatory operations experts have extensive knowledge and experience in project management as well as in submission and procedural management and can partner with you at any point in the process to collect and organize the data, publish it in Electronic Common Technical Document (eCTD) format, send registration files, correspond with the right authorities at the right time, and compile, analyze, and prepare additional data needed to answer questions that arise during assessments.

We can support you by providing:

  • Dossier Compilation and Publishing: We can assist with regulatory strategy development as well as writing and preparation of dossier modules to make sure that all regulatory requirements are fulfilled. Through gap analysis, our experts can find and resolve any issues prior to submission. Our publishing team prepares your application for submission to the relevant health authorities
  • Submissions and Procedural Management: We can support the submission of your application and guide you through the necessary steps of the assessment procedure, keeping you fully informed on your application status and following up with authorities to ensure that any questions are properly responded to and that the application process runs smoothly
  • Act as Local Contact with Health Authorities: We understand what registration documentation or variational action is required by the different health authorities and how it should be presented. We handle the contact and dialogue with regulators to smooth the application process for you
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