Regulatory Services

Our Regulatory Services include:

🗂️ IRB/IEC and Competent Authority (CA) Initial Submissions & Approval Tracking

We prepare and submit comprehensive initial application packages to Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), and Competent Authorities (CAs). We also provide ongoing tracking and communication to ensure timely approvals and mitigate delays.

📨 Regulatory Submissions and Follow-Up During the Study

From site activations to study updates, we manage all regulatory communications and submissions throughout the trial. Our team ensures that regulatory obligations are met consistently, and follow-ups are tracked and resolved efficiently.

✏️ Amendments and Annual Notifications

We handle protocol amendments, investigator brochure updates, and annual safety reports, ensuring that all changes are submitted to the appropriate authorities in a timely and compliant manner.

📦 Substantial Submissions

Our regulatory team is experienced in preparing and submitting substantial modifications and safety-related updates, maintaining alignment with country-specific guidelines and sponsor expectations.