Regulatory Affairs

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
  • Clinical Evaluation
  • 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.

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