Pulse Clinical stands at the forefront of Regulatory Oversight, providing specialized services to guide clinical trial sites across Australia and New Zealand through the intricacies of regulatory compliance, with particular emphasis on meeting the standards set by the Therapeutic Goods Administration (TGA). Our Regulatory Oversight services include a comprehensive understanding and implementation of the Electronic Clinical Trial Notifications (eCTNs) based on the latest guidelines and information from the TGA website.

Our Approach

TGA Compliance Excellence

Pulse Clinical places paramount importance on aligning clinical trials with TGA regulations. Drawing insights from the latest updates on the TGA website, our team ensures your study meets and exceeds the rigorous standards mandated by the TGA. From meticulous documentation preparation to submission and continuous compliance, we offer comprehensive solutions that prioritize adherence to the latest TGA requirements.

eCTN Submission Specialization

Staying abreast of the eCTN processes outlined on the TGA website, our experts specialize in handling Electronic Clinical Trial Notifications with precision. Pulse Clinical streamlines the submission process, ensuring that your electronic notifications are not only compliant but also in line with the latest guidelines, facilitating faster regulatory approvals.

Leverage our in-depth understanding of TGA regulations, integrating the latest insights from the TGA website to ensure your study aligns with Australian regulatory standards.

Key Services

Regulatory Documentation Management

Our Regulatory Oversight services encompass the comprehensive management of all regulatory documentation, integrating insights from the eCTN section of the TGA website. From Investigational Medicinal Product Dossiers (IMPDs) to site-specific documentation, we ensure that every piece of regulatory information is meticulously prepared, reviewed, and submitted in alignment with the latest TGA guidelines.

eCTN Submission Handling

Pulse Clinical takes a proactive stance in adapting to the evolving guidelines on the TGA website related to eCTN submissions. We navigate the electronic platform seamlessly, preparing and submitting notifications with precision and ensuring that your study initiation aligns seamlessly with the most up-to-date regulatory standards.

Regulatory Compliance Audits

To maintain ongoing compliance, our team conducts regular audits informed by the latest information available on the TGA website. These audits ensure that your trial continues to meet TGA standards and other regulatory requirements, reducing the risk of regulatory queries and facilitating a smooth study conduct.

Trust Pulse Clinical to be your strategic partner in Regulatory Oversight, where TGA compliance, eCTN efficiency, and the latest regulatory insights converge. Contact us today to explore how our services can elevate the regulatory aspects of your clinical trials, ensuring a smooth and compliant study start-up process.

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