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.