Our data-driven approach to regulatory intelligence delivers a superior regulatory intelligence service.

 

Our dedicated team of regulatory intelligence specialists provides continuous surveillance of the regulatory environment to ensure awareness of upcoming changes, requirements and updates that may affect our clients’ product portfolios.

Deciphering requirements, validating agency expectations and performing impact analyses ensure we always remain compliant and proficient with national/global regulations as well as reporting standards for regulatory, pharmacovigilance and drug safety.

Our dedicated regulatory intelligence experts cover:

  • Chemistry, manufacturing, and control (CMC)
  • Advanced therapy medicinal product (ATMP)
  • Genetically modified organisms (GMO)
  • Device and in vitro diagnostics (IVD)
  • Compassionate use/named patient programs
  • e-Consents
  • Virtual trials
  • Home nursing
  • Telemedicine.