Regulatory Affairs

Research Services

We help you navigate the complexities of clinical trial regulatory submissions and affairs with ease.

Why choose our partner network?

Navigating the ever-changing regulatory landscape of clinical research is no easy task. Our qualified partners support you on this journey, equipping your clinical trial endeavours with a deep understanding of regional and international regulatory requirement.

Our approach to regulatory affairs

With a team of seasoned experts in regulatory affairs, we meticulously guide you through the complex process of obtaining approvals, adhering to guidelines, and meeting all regulatory obligations. Our holistic approach encompasses strategic planning, document compilation, submission management, and ongoing liaison with regulatory.

Triall has built a network of selected CRO partners who each excel in their respective domain, allowing us to offer you a truly end-to-end service offering. Each partner has undergone a rigorous vendor qualification to ensure our services meet the highest standards.

Regulatory Strategy Development

We help you craft a custom-tailored roadmap to navigate the regulatory requirements specific to your study. We align your study objectives with a comprehensive strategy that accelerates approvals while maintaining the highest ethical and safety standards.

Submissions & Approvals

Our experts can manage the preparation, compilation, and submission of regulatory documents to expedite approvals. We engage in proactive dialogue with regulatory bodies and ECs/IRBs, addressing inquiries promptly and ensuring a smooth review process.

Compliance Oversight

We continuously monitor evolving regulatory guidelines to ensure your study remains aligned with new regulations. We offer ongoing support to implement necessary adjustments, maintaining study continuity and compliance.

Global Regulatory Intelligence

Equipped with up-to-date knowledge of international regulations, we guide you through the complexities of multi-national trials, ensuring consistency and compliance across diverse regulatory landscapes.

Expert Regulatory Guidance

Tap into the expertise of our seasoned regulatory professionals who remain up-to-date with the ever-evolving regulatory landscape.

Expedited Regulatory Approvals

Our strategic approach to regulatory affairs helps you expedite the process of obtaining regulatory approval, thereby minimising delays in study startup and initiation.

Risk Reduction

Through proactive risk assessment and mitigation efforts we protect your clinical trial from unforeseen regulatory hurdles.

Confidence in Compliance

Partnering with us ensures your studies are conducted ethically and in accordance with all applicable regulations, enhancing the integrity and reliability of your research.

Faster Time-to-Market

Streamlined regulatory processes result in faster time-to-market, allowing you to expedite the introduction of your innovative treatment to patients in need.

Interested in this service?

Our specialists are available to answer your questions. Reach out to us and explore opportunities to match your clinical research needs today.

Did you know we also offer eClinical solutions?