Regulatory Affairs
We provide end-to-end support for product registration and lifecycle management across Sub-Saharan Africa.
- Product registration strategy and dossier preparation
- Product life cycle management
- Regulatory intelligence and market entry strategy
- Post-approval regulatory support
- GMP compliance assessments and audits
Quality Assurance
Ensuring your products meet the highest standards of safety and efficacy through rigorous quality oversight.
- Quality management system implementation
- GXPs Implementation
- Corrective and preventive actions (CAPA)
Pharmacovigilance
Comprehensive drug safety monitoring solutions to protect patients and maintain regulatory compliance.
- Submission of Individual Case Safety Reports (ICSR)s to NRAs
- Aggregate safety reporting (PBRER/PSUR/DSUR)
- Local Literature screening
- QPPV oversight
- Regulatory intelligence tracking
- PV system establishment and governance
- Compliance audits & GAP assessments
- PV training for internal teams & partners
- Metrics and KPI reports
Training
Empowering your team with the knowledge and skills needed to navigate the regulatory environment effectively.
- GMP and GDP training programs
- Pharmacovigilance training
- Regulatory affairs workshops
- Customized on-site and virtual training solutions
