Top-notch regulatory services
Our team of experienced regulatory experts is well-versed in the constantly evolving regulatory landscape and can help you navigate the intricacies of regulatory compliance seamlessly. From initial study documentation to submission and approval we’ve got you covered every step of the way.
Our regulatory services include:
Protocol Development and Review: We assist in developing and refining study protocols ensuring they align with regulatory standards and guidelines. Our thorough review process helps identify potential gaps or concerns minimizing the risk of non-compliance and ensuring ethical considerations are met.
Investigational New Drug (IND) Application: We provide comprehensive support in preparing and submitting IND applications to regulatory authorities. Our team ensures that all necessary documentation is included helping accelerate the approval process and saving you valuable time.
Institutional Review Board (IRB) submissions: We assist with the compilation and submission of IRB packages streamlining the review process and ensuring compliance with ethical standards and regulations.
Clinical Trial Application (CTA) Preparation: Our regulatory experts compile and submit CTA documentation to regulatory authorities handling all aspects of the process and ensuring a smooth review and approval.
Regulatory Compliance Audits: We conduct thorough audits to assess your study’s compliance with applicable regulations identify areas for improvement and mitigate risks of non-compliance. Our team provides detailed reports and recommendations ensuring you are well-prepared for regulatory inspections.
Pharmacovigilance Support: We offer support with adverse event reporting safety monitoring and pharmacovigilance activities to ensure continuous compliance with safety regulations and reporting obligations.
At Clinique Research Services, we understand the critical role regulatory compliance plays in the success of your clinical study. With our regulatory services you can focus on your research while we handle the complex regulatory requirements. Let us be your trusted partner in achieving regulatory excellence.