Pharmacovigilance Support

Our pharmacovigilance (PV) experts including experienced PV physicians, licenced Medical Doctors (MDs) in collaboration with our medical writing group, we provide high-quality complete package pharmacovigilance and regulatory affairs services to help the pharmaceutical industry make safe and effective healthcare products available in Sub-Saharan Africa. 

Our services include:

• Setting up, host and maintenance of local pharmacovigilance safety database including local PSMF, local SOPs.
• Development of Safety Management Plans
• Preparation and submission of periodic safety update reports (PSURs), safety update reports (DSUR) 
• Development of Medical Monitoring Plans
• Development of Risk Management Plans
• Medical coding of AEs and medications (MedDRA, WHO Drug Dictionary)
• Serious Adverse Events (SAEs) and safety information review
• Acting as the medical point of contact for Investigators and sites and medical consultations
• Continuous medical support on eligibility, issues, or concerns
• Causality assessment discussions
• Provision of Local Persons for Pharmacovigilance with assurance of 24/7 availability where required.
• End-to-end local and global literature safety surveillance activities
• Handling of requests and inspections from local Competent Authorities
• Development of Summaries of product characteristics (SPCs) and Package Leaflets (PL)
• Package Leaflet Readability User Testing (RUT) or Bridging Reports
• Regulatory compliance oversight