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.

Our expertise goes beyond the scope of simply providing health product regulatory consultation and dossier preparation. SPharm provides the advantages of a true partnership by ensuring that its experience and services are fully integrated with your company’s internal procedures and strategic objectives that ultimately save you time and money.

Regulatory

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

Product Development

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

Pharmacovigilance

  • 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.

Insights/Blog

Covid-19 Clinical Trials worldwide September update
Covid-19 Clinical Trials worldwide August update
Worldwide Covid-19 Clinical Trials July update