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

  • 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

SPHARM, YOUR BUSINESS PARTNER

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