Services
Pharmacovigilance
Pharmacovigilance that stands up to inspection
A named qualified person for pharmacovigilance, adverse event reporting to the Pharmacy and Poisons Board, periodic safety reports and safety signal management.
A qualified person responsible for the safety of your products in Kenya, with a named deputy, available to the regulator.
Receiving, assessing and reporting adverse events to the Pharmacy and Poisons Board on time.
Periodic safety update reports written, reviewed and submitted on schedule.
Detection, validation and follow-through with documented decisions.
The master file that describes your safety system as it really runs.
Global and local medical literature checked for safety information and logged.
RMPs and risk minimisation measures adapted to local practice.
Regulatory Affairs
Registrations that get through first time
Product registration with the Pharmacy and Poisons Board and other East African regulators, dossiers, variations, renewals and local representation.
Registration of medicines, medical devices and health products with the Pharmacy and Poisons Board and other East African regulators, including EAC joint assessment where it applies.
Dossiers in the Common Technical Document (CTD) format, checked against current guidance before submission.
Changes and renewals filed on time so your registration never lapses.
A Kenya-based representative for manufacturers outside Kenya, as the Pharmacy and Poisons Board requires.
Quality & Compliance
Inspection-ready, every day
Pharmacovigilance audits, inspection readiness and written procedures that reflect how your team really works.
Independent audits of your pharmacovigilance system against good pharmacovigilance practice.
A clear plan and evidence pack before the regulator arrives.
A realistic rehearsal with findings and a corrective action plan.
Written procedures that describe how your team really works, and stand up to an inspection.
Medical Information
Medical information handled properly
A medical information service that answers questions about your products and captures adverse events.
Training
Training that builds in-house capability
Pharmacovigilance and regulatory affairs training for your staff, online or at your premises.
Market Access & Advisory
Decisions based on current rules
Advice on entering the Kenyan and East African markets and keeping up with regulatory changes.