Pharmacovigilance and Regulatory Support

Specialist writing for pharmacovigilance and regulatory compliance

Tinctes provides specialist pharmacovigilance and regulatory writing support for pharmaceutical companies, marketing authorisation holders and regulatory service providers across African markets – from PSURs/PBRERs, risk management plans and PSMFs to SOPs and supporting documentation.

We also offer literature screening, regulatory intelligence and QPPV support to strengthen pharmacovigilance and regulatory compliance.

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Better Decisions. Safer Tomorrows.
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

Support with report planning, authoring, review and submission-ready documentation.
 Risk Management

RMPs & aRMMs

Risk management plan development and updates, additional risk minimisation materials, PV plans and alignment of supporting documents.
PV SYSTEM DOCUMENTATION

PSMFs & annexes

Pharmacovigilance system master file writing, maintenance and annex updates, with document consistency in mind.
 QUALITY DOCUMENTATION

SOPs, WIs & templates

Practical procedures, work instructions, trackers and templates designed to make responsibilities and processes easier to follow.
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.

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