At Dr. Mwiko Health Solutions Ltd, we support pharmaceutical companies in developing, maintaining, and harmonizing their Pharmacovigilance System Master Files (PSMFs) both at the global and local (Kenyan and African) levels.
We ensure that your PSMF accurately reflects the structure, processes, and performance of your pharmacovigilance (PV) system in full alignment with GVP Module II, EMA, FDA, and local regulatory requirements. We help you demonstrate control, compliance, and continuous oversight of your PV activities through precise documentation, efficient governance, and regular updates.
Our PSMF Management Services
- PSMF Development & Setup Creation of global or affiliate-level PSMFs that are fully compliant with local and international regulations, tailored to your company’s organizational structure and product portfolio.
- Local PSMF Adaptation Preparation of country-specific annexes for Kenya and other African markets to capture local pharmacovigilance activities, qualified personnel details, regulatory commitments, and reporting mechanisms.
- Ongoing Maintenance & Governance Periodic review, update, and version control of PSMFs to ensure accuracy of data related to organizational changes, safety system updates, and evolving compliance requirements.
- Audit & Inspection Readiness
Ensuring that your PSMF and all supporting documentation are audit-ready, consistent with the safety database, and aligned with regulatory expectations during inspections or due diligence reviews.
- Integration with Quality Systems
Linking your PSMF to standard operating procedures (SOPs), CAPA systems, and quality documents to create a unified compliance framework.
- Outsourced PSMF Management
For organizations without in-house pharmacovigilance infrastructure, we provide complete outsourced PSMF management — including authoring, maintenance, hosting, and version tracking — under a secure and validated system.
Why Partner with Dr. Mwiko Health Solutions
- Regulatory Alignment: Full compliance with EU GVP, FDA, and Local (African) national PV guidelines.
- End-to-End Expertise: From system setup to inspection support, we manage every aspect of your PSMF lifecycle.
- Local Insight, Global Standards: Deep understanding of African PV frameworks combined with global regulatory best practices.
- Confidentiality and Integrity: Secure handling of proprietary data with validated document management systems.
At Dr. Mwiko Health Solutions, we ensure that your Pharmacovigilance System Master File becomes a living, compliant, and inspection-ready document reflecting the true strength of your safety system and commitment to patient protection.
