General Regulatory Activities

We can also provide support in the following activities according to your company needs (tailored on-demand):

  • Develop comprehensive reports on the regulatory framework (legislation, guidance, requirements) applicable to specific projects
  • On-site consultancy support through the placement of regulatory staff
  • Medical devices legislation, labelling and submissions
  • Cosmetics legislation, labelling and registration
  • Due diligence activities
  • Regulatory compliance activities (review approved dossier information against technical information used for product manufacturing and testing)
  • PIL User Testing and preparation of final report for submission
  • Prescription to OTC switches
  • Dossier re-format from NTA to CTD format