Technical Assistance
For Life Sciences organizations, CMC (Chemistry, Manufacturing, and Controls) services are crucial in maintaining compliance with regulatory standards. At Registitute, we specialize in providing comprehensive support to streamline the regulatory documentation process, and submission requirements. Our expertise lies in developing effective strategies and documentation that align with complex, country-specific requirements. Whether you need assistance with CMC, pharmaceutical product registration, or submission, we are here to help you navigate the regulatory landscape seamlessly.
Furthermore, our services ensure the timely submission of documentation in acceptable formats; NeeS and eCTD and assist with the Drug Master File (DMF) Submission. Our expertise can facilitate the implementation of best practices to enhance the quality and efficiency of the Regulatory Documentation process.
We offer a comprehensive solution to simplify the creation of technical documentation/ Site Master File for Medtech. We provide a range of ready-to-use templates that can be customized to your specific needs, allowing you to focus on the content rather than the format.
Our templates cover a wide range of requirements, from SOPs such as Risk Management and Change Management, to specific reports like Clinical Evaluation Reports (CERs), Post-Market Surveillance Reports (PMSRs) and/or Periodic Safety Update Reports (PSURs).
With our support, you can ensure that your technical documentation is of the highest quality, meets regulatory requirements, and is ready for submission.