Ergomed’s Regulatory Affairs Services: Your Global Partner in Compliance and Success

At Ergomed, our data-driven, reliable, and globally positioned regulatory affairs team is dedicated to helping you meet your targets precisely and efficiently. Strategically located across the U.S. and Europe, our teams are well equipped to offer comprehensive global regulatory consulting and lifecycle management. We have a deep understanding of both local and international regulations, ensuring your compliance and success.

Global Regulatory Framework Assessment Tool

This heat map assesses the suitability of the country’s regulatory framework based on your protocol. Simply enter details of your trial design to see which countries will facilitate fast approval and which ones will be more challenging. The fastest countries will be colored the darkest, more challenging the lightest, and white where it’s not possible. These are estimates based on a number of variable factors. Each project is unique and we would be happy to provide you with tailored analysis based on more specific project details and milestones.

Extensive Experience in Regulatory Submissions

Our regulatory affairs teams, with extensive expertise and experience, are adept at preparing all major regulatory dossiers, including complex multinational submissions.

We offer comprehensive support for the preparation and submission of the following regulatory documents:

  • Clinical Trial Authorization/Application/Exemptions (CTA/CTX)
  • Clinical Trial Notifications (CTN)
  • Common Technical Document (CTD)
  • Investigational Drug Exemptions (IDE)
  • Investigational New Drug Applications (IND)
  • Marketing Authorization Applications (MAA)
  • New Drug Applications (NDA)
  • Biologics License Application (BLA)
  • Abbreviated New Drug Application (ANDA)
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Regulatory Project Management and Quality Control

Ergomed’s regulatory project management oversight ensures that all regulatory activities are meticulously planned and executed. Our regulatory managers provide comprehensive oversight, coordinating all aspects of the regulatory process. Additionally, our quality control review of each document guarantees that submissions are accurate and compliant, minimizing the risk of delays and rejections.

Data-Driven Methodology

At Ergomed, we leverage advanced data analytics to inform our regulatory strategies. This innovative approach allows us to anticipate potential challenges and devise practical solutions, ensuring your regulatory submissions are optimized for success. We stay ahead of the curve by continuously monitoring and analyzing regulatory trends, providing our clients with the insights needed to navigate the evolving regulatory landscape.

Let Ergomed Support Your Clinical Development Journey

Ergomed’s regulatory affairs services are about compliance and supporting your clinical development journey from start to finish. With our global presence, comprehensive lifecycle management, and data-driven approach, we provide reliable and effective regulatory support you can trust.

Dedicated Partnership, Ergo, Successful Outcomes

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