Our Regulatory Support services include but are not limited to: 

• Comprehensive Regulatory Support: Devising tailored strategies to ensure compliance with local and international requirements, empowering clients to proactively manage compliance risks.
• Compliance with Regulations and Guidelines: Performing all assigned tasks in strict adherence to ICH GCP, relevant regulations, and guidelines, keeping abreast of regulatory changes, and obtaining necessary approvals in a timely manner.
• Regulatory/Ethics Preparation & Submission: Assisting with regulatory and ethics submissions, including IRB/EC and HREC submissions, ensuring compliance with site-specific governance requirements and facilitating the development of site-specific PICF (Participant Information and Consent Form).
• Consultations and Liaison: Providing customized regulatory consultations and services, liaising with sites and investigators to address regulatory requirements and facilitate smooth study operations.
• Trial Master File (TMF) Support: Offering support for the organization and management of electronic and paper Trial Master Files, ensuring the collection and maintenance of site essential documents, and providing TGA eCTN submission and management services as needed.

Take advantage of our free consultation to learn more about our customized services.