As global regulatory requirements continue to evolve and grow, it has become more difficult to navigate through them. CTNT provides regulatory affairs services for pharmaceutical and medical device products. Our expertise enables us to plan and execute the best regulatory strategy for your product, increasing your chances of gaining regulatory approval with the least obstacles.
CTNT provides support for the entire process, from the regulatory definition of your product, through submissions and interactions with the regulatory authorities until the final stage of the approval process.
Our regulatory strategy services include:
Consultation and development of strategies to support specific regulatory authority requirements
Assistance in classification of medical device
Guidance for optimizing testing packages throughout the non-clinical and clinical program
Regulatory due diligence to define and analyze needs and gaps (CMC, Non-clinical, clinical)
FDA 510(k), 510(k) De Novo, PMA Pre-submissions, Pre-IDE and IDE submissions and meetings
Listing and registration with the FDA
Creating Quality Management Systems (QMS) and regulatory authorities’ simulated inspection
EU CE Mark activities
Post Clinical Follow Up in compliance with applicable regional regulatory requirements
New European MDR (medical device regulation) implementation
Biological Evaluation and assistance in handling relevant product tests in compliance with ISO 10993-1
Liaison with FDA, notified bodies, registration bodies and competent authorities
Development of product-related regulatory plans and product verification and validation
Implementation of technical aspects of standards and testing as well as certification issues
Investigation and reporting of incidents and adverse events
Handling risk management processes in accordance with relevant ISO regulation
Technical and scientific writing
Yearly Technical File review and update
Yearly surveillance audits following notified body approval and CE marking of medical devices.
We have the experience and flexibility to develop high quality documents to meet your specific needs.