Regulatory surveillance

Requirements in regulations, and those made by notified bodies, can be challenging, when adequate regulatory competence is expected.

We can help you with:

  • Surveillance of standards and regulation changes for your product types
  • Efficient CAPA processes
  • Planning and conducting Field Safety Corrective Actions and recalls
  • Drafting non-filing justifications (FDA)
  • Adverse event and Vigilance reporting to competent authorities and the FDA

Contact me for further information
Nils-Åke Lindberg
Office +46 46 286 88 90 or send me an e-mail