Pharmacovigilance & Regulatory Services
Tinctes provides specialist support for pharmacovigilance documentation, literature screening, regulatory intelligence, PV system activities and quality processes. Engagements are scoped around the product, market, deliverable, timeline and responsibilities agreed with each client.
SPECIALIST WRITING SERVICES
Regulatory documents that are clear, structured and ready for submission.
Flexible writing and document-development support for teams that need specialist capacity, dependable turnaround and careful attention to applicable requirements.
AGGREGATE SAFETY REPORTS
PSURs & PBRERs
Risk Management
RMPs & aRMMs
PV SYSTEM DOCUMENTATION
PSMFs & annexes
QUALITY DOCUMENTATION
SOPs, WIs & templates
Additional specialist support
More than document writing.
Literature Monitoring
Covering global and local journals including tracking.
REGULATORY INTELLIGENCE
Monitoring regulatory changes and providing market specific updates across Africa.
QPPV & PV SYSTEM SETUP
Local QPPV support, PV System setup and oversight activities.
PV WORKFLOW & SOFTWARE TESTING
PV Workflow reviews, user acceptance testing and product feedback.
OUR APPROACH
Regulatory expertise. Real-world perspective
We combine technical regulatory knowledge with hands-on pharmacovigilance and quality experience to deliver solutions that are practical, compliant and built for Africa and beyond.
- Precision
Because safety and compliance leave no room for guesswork.
- Integrity
We do what is right, always
- Partnership
Your goals are our goals.
- Forward thinking
Today’s challenges. Tomorrow’s solutions.
Need additional PV or regulatory support?
Tell us about your project, documentation requirements or ongoing support needs. We’ll discuss the scope, timelines and an appropriate way to work together.