Management of Clinical Trial Regulatory Services in FDA and EMA Territories

Navigating the complex regulatory landscape for clinical trials requires expertise and precision. Our dedicated team is committed to ensuring your clinical trials meet all regulatory requirements in both FDA and EMA territories. With our comprehensive regulatory services, you can focus on your research and development while we handle the compliance aspects.

Regulatory Strategy Development

  • Tailored regulatory strategies to meet specific trial requirements and objectives.
  • Detailed planning and risk assessment to ensure smooth regulatory processes.

Preparation and Submission of Regulatory Documents

  • Expertise in preparing Investigational New Drug (IND) applications for the FDA.
  • Comprehensive preparation of Clinical Trial Applications (CTA) for the EMA.
  • Ensuring all documentation meets the highest standards of accuracy and compliance.

Liaison with Regulatory Authorities

  • Direct communication and coordination with the FDA and EMA on your behalf.
  • Efficient management of regulatory submissions and responses.
  • Expert negotiation and representation during regulatory meetings and reviews.

Ongoing Compliance Monitoring and Reporting

  • Continuous monitoring to ensure ongoing compliance throughout the trial.
  • Detailed reporting and documentation to maintain regulatory adherence.
  • Proactive identification and resolution of compliance issues.

Support in Regulatory Meetings and Negotiations

  • Preparation for regulatory authority meetings, including briefing materials and presentations.
  • Strategic guidance and representation during regulatory discussions and negotiations.

Let Us Simplify Your Regulatory Journey

We understand the complexities involved in managing clinical trial regulations and are dedicated to providing you with reliable, efficient, and thorough regulatory management services. Partner with us to ensure your clinical trials are compliant and positioned for success in both the US and EU markets.

Contact us today to learn more about how we can support your clinical trial regulatory needs and help you bring your products to market with confidence.

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