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