Regulatory Consultancy Services

Global Strategies to Align Your Goals With Regulatory Requirements

Ergomed’s regulatory consultancy services are guided by a team of seasoned consultants, each bringing a wealth of experience from regulatory agencies and in-house roles. This expertise ensures a proactive and flexible solution tailored to your project’s unique needs and timelines, instilling confidence in our services.

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Defining Your Regulatory Campaign

Our regulatory affairs consultants are adept at devising global strategies aligning commercial goals with regulatory requirements. Whether you need assistance compiling a Common Technical Document (CTD), managing complex phase IV clinical trials, or handling Chemistry, Manufacturing, and Controls (CMC) post-approval changes, Ergomed has the expertise to support your project. Our in-country teams facilitate global or local submissions, ensuring compliance and efficiency across all regulatory processes.

Tailored Regulatory Consultancy Services

Our bespoke regulatory affairs consultancy service begins with an initial feasibility assessment to review the available data before developing a full proposal. A lead consultant and a dedicated team of experts are assigned to your project, ensuring focused and consistent support. The regulatory strategy will detail supplementary data requirements, applicable governing regulations, and a program schedule to meet even the most demanding timelines.

Comprehensive Regulatory Support

Ergomed’s regulatory affairs consultancy service encompasses a wide range of support activities, including:

  • Regulatory Strategy Definition
  • Gap Analysis and Due Diligence Assessments
  • Scientific Advice
  • Orphan Drug Designation Applications
  • Clinical Trial Authorization (CTA) Filings
  • Investigational New Drug (IND) Filings
  • Pediatric Investigation Plans (PIP)
  • Initial Pediatric Study Plan (iPSP)
  • Fast Track and Breakthrough Applications (FDA)
  • Priority Medicines (PRIME) Designation (EMA)
  • Marketing Authorization Applications (MAA)
  • New Drug Applications (NDA)
  • Biologics License Applications (BLA)
  • Abbreviated New Drug Applications (ANDA)
  • Launch and Post-Registration Activities

 

Proactive and Flexible Solutions

At Ergomed, we recognize that regulatory requirements and timelines can shift unexpectedly. That’s why our regulatory consultants are always ready to adapt to these changes. We offer proactive and flexible solutions that keep your project on course and safeguard its success. Our data-driven approach, informed by the latest insights and trends, enables us to anticipate challenges effectively and mitigate risks, providing the assurance you need in your project’s regulatory journey.

Unwavering Commitment to Success

At Ergomed, we are deeply committed to your success. We strive to provide comprehensive regulatory affairs services tailored to your specific needs. Our consultants work closely with your team, fostering a collaborative environment that enhances communication and exceeds all regulatory milestones. This unwavering commitment to your success is the driving force behind everything we do.

Tailored Regulatory Consultancy Services

Discover how Ergomed’s regulatory affairs services can support your clinical research and regulatory needs.

Contact us today to learn more about our tailored regulatory consultancy services and how we can help you navigate the complex regulatory landscape with confidence.

Regulatory Expertise, Ergo, Assured Compliance

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