Pharmacovigilance
A named qualified person for pharmacovigilance, adverse event reporting to the Pharmacy and Poisons Board, periodic safety reports and safety signal management.
Regulatory Affairs
Product registration with the Pharmacy and Poisons Board and other East African regulators, dossiers, variations, renewals and local representation.
Quality & Compliance
Pharmacovigilance audits, inspection readiness and written procedures that reflect how your team really works.
Medical Information
A medical information service that answers questions about your products and captures adverse events.
- Medical information service
- Adverse event intake
Training
Pharmacovigilance and regulatory affairs training for your staff, online or at your premises.
- Pharmacovigilance training
- Regulatory affairs training
Market Access & Advisory
Advice on entering the Kenyan and East African markets and keeping up with regulatory changes.
- Market entry advice
- Regulatory updates and intelligence
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Quality & Compliance
Standard operating procedures

Quality & Compliance

Standard operating procedures

Written procedures that describe how your team really works, and stand up to an inspection.

Book a PV system review See what’s included

Standard operating procedures

Related services

Pharmacovigilance audits

Independent audits of your pharmacovigilance system against good pharmacovigilance practice.

Inspection readiness

A clear plan and evidence pack before the regulator arrives.

Mock inspections

A realistic rehearsal with findings and a corrective action plan.

Ready to talk about standard operating procedures?

Book a PV system review