Ensuring compliance in a complex regulatory landscape

Achieving a successful market entry involves meeting regulatory standards and ensuring adherence to product safety and performance requirements. Our comprehensive support covers reviewing GSPR checklists, identifying and choosing notified body, guiding you to submitting comprehensive technical documentation, and boosting your efficient market access. We guide you in obtaining the CE mark and PRRC services, acting as representatives in EU and UK markets and helping you with local registrations. Our experience, particularly in pre-submission meetings with the FDA and pre-market submissions, ensures efficient and smooth access to the US market. With a strong and extensive background, our experts provide real-time insights and customized training to keep you up to date.

Expertise, support, and strategic guidance with diverse authorities

  • We provide effective support, thanks to our communication and industry knowledge, to facilitate smooth collaboration among involved teams and stakeholders.
  • Our worldwide expertise will guide you in understanding all regulatory changes and providing the latest information, trends, and developments in the industry.
  • Our in-depth knowledge will help you through the activities to establish a strong market presence with an efficient regulatory strategy.
  • We have a strong track record in assisting our clients in achieving secure access to the market.
PLG can effectively guide through achieving market access thanks for the great support in dealing with notified bodies and competent authorities.

Leading MedTech Client

MedTech Client – Medical Device Regulatory Services