Opening Hours: Weekdays 8.00-20.00

Tag line – identify, analyse, and react in real-time to regulatory change. Potential areas of risks and impact are rapidly communicated to our sponsors, with mitigation strategies implemented to ensure compliance of all clinical development and trial activity

 

Our experienced team regulatory and safety experts with regional and global knowledge will work with you to provide a structure and that best fits your needs. Such services include:

  • Preparation and submission of clinical trial applications to regulatory authorities a d facilitating ongoing regulatory requirements
  • Supporting investigators with the preparation and submission of Institutional Review Board or Ethics Committee documentation and facilitating completion of ongoing Institutional Review Board or Ethics Committee requirements
  • Import/export permits for investigational product and biological samples
  • Investigational product management, including distribution to and from depots and trial sites
  • Local labelling review
  • Regulatory safety reporting

Local Safety and Pharmacovigilance and/or Regulatory Responsible Persons

 

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