Explore SPharm’s Regulatory Services

Effective management of drug development plans, Clinical Trial Applications and marketing authorizations require thorough knowledge of current regulations and an excellent product development strategy.


  • Regulatory submissions
  • Lifecycle management for drugs and medical devices
  • Complementary services

Product Development

  • Due diligence
  • Strategic health product development
  • Brand name analysis


  • Clinical trials and Post-marketing surveillance programs
  • Risk Management Plans (RMP)
  • Pharmacovigilance training

Compliance and Quality

  • Quality due diligences
  • Drug Master Files (DMF)
  • Establishment Licences (EL)

Services through our partners

  • Foreign regulatory affairs
  • Ethics Review Board
  • In vivo nonclinical studies
  • Monitoring of Clinical Studies
  • Clinical trial report writing
  • Statistical analysis

Training & Consulting Services

Spharm provides training services to individuals and organizations to enable a practical understanding of the drug regulatory approval processes.

We offer both custom and standard training sessions. Learn more about some of the modules we cover in our training.