Regulatory Affairs

REGULATORY AFFAIRS GUIDING YOU TO APPROVAL

Regulatory

A well-designed regulatory strategy considers not only European and international regulations, but also development costs, development cycles, and profitability concerns. We work side-by-side with you to design and implement a competitive and cost-effective regulatory strategy, prepare and submit a reviewer-friendly technical documentation, assist you in negotiating with national and international notified bodies, FDA, and international regulatory agencies quickly and effectively.

We provide deep sector and regulatory expertise at all stages in your drug or medical device lifecycle, from pre-clinical assessment to clinical trials, CE marking and post market surveillance.

Our regulatory team is composed of specialists and consultants with years of experience in all phases of product development, thus and that have participated in international regulatory technical committees. This enables us to have a holisitic and unmatched approach to advising our clients on how to best develop and implement there regulatory strategy to achieve product approval.

1MED therefore meets even the most exacting standards of international regulatory agencies, maximizing the cost-effective use of your company’s resources and anticipating potential regulatory issues.

OUR TURNKEY SERVICES

  • Regulatory assistance and strategies for CE marking and FDA approval
  • Regulatory plan & gap analysis
  • Preparation of a full technical file/design dossier
  • Risk assessment (ISO 14971)
  • Device registration
  • CAPA support
  • Quality strategy, maintenance and certification (ISO 9001, ISO 13485)
  • Medical devices post-market surveillance plan
  • Post market clinical follow-up
  • Post market performance follow-up
  • Labelling – product leaflets and instructions for use review
  • Regulatory and quality training
  • Third party regulatory compliance