At TM RA Consultancy, our highly qualified team stands by your side, providing essential support in the event of receiving a deficiency letter from ANVISA.
Our comprehensive assistance includes clarification of the agency’s requests, guiding you in the preparation of responses and necessary documentation, and ensuring compliance with ANVISA’s requirements in a precise manner.
Our specialized services encompass:
- Deficiency Letter Handling: In cases where the regulatory agency issues a deficiency letter, we conduct meetings to explain the required items and the documentation expected by ANVISA.
- Technical-Regulatory Evaluation: Our team conducts a technical-regulatory evaluation of responses and documents prepared by the API manufacturer, ensuring alignment with Anvisa’s stringent standards.
- Response Application: We assist in the submission of the documentation for compliance with requirements on Anvisa’s system, ensuring a smooth and easily handled process.
With TM RA Consultancy, you can trust that your response applications will be managed efficiently and that every regulatory requirement will be met precisely.
