At TM RA Consultancy, we are dedicated to providing extensive assistance for your CADIFA application.
Our exceptionally skilled team will stand with you, delivering the essential support throughout the process.
This encompassing service involves:
- Technical-Regulatory Evaluation of DMF: Our team conducts a technical-regulatory evaluation of the Drug Master File (DMF), focusing on developing documentation that aligns with Anvisa’s requirements.
- DMF Improvement: We ensure that the DMF is complemented as needed to meet all the requirements specified by Anvisa for CADIFA issuance. This service considers the technical criteria established by Brazilian legislation in force and international guidelines, such as ICH guidelines.
- Application Forms and Statements: We handle the preparation and submission of all mandatory forms and statements required for the CADIFA application, ensuring documents are compliant with Anvisa’s standards. This process includes the company’s registry on Anvisa’s system to obtain the DHN (DIFA Holder Number).
- Monitoring Notifications from Anvisa: We keep a close eye on notifications from Anvisa related to the process, addressing any additional requirements or information promptly.
By partnering with TM RA Consultancy, your CADIFA application will be more efficient and professionally managed.
