Controlled Correspondence (CC) is a formal communication channel between industry stakeholders and the FDA. It allows manufacturers to seek clarity on regulatory, scientific, and administrative matters related to drug development, submission, approval and post approval.

      Timely and accurate responses to Controlled Correspondence from the FDA can provide crucial advice on issues such as the Q1/Q2, MDD, BET, Stability orientation, acceptability of proposed methodologies and many more. Leveraging this communication effectively can significantly enhance the efficiency of the approval process, mitigate risks, and ensure that submissions align with FDA expectations.

     iTechnicalTools provides a specialized Controlled Correspondence template, designed to help companies draft clear, precise, and compliant queries to the FDA. Our template streamlines the process, ensuring that your submissions are aligned with FDA expectations, reducing the risk of delays, and enhancing the overall efficiency of your regulatory communications.