FAQ
Frequently asked questions
Pharmacovigilance, product registration and working with PVRA Solutions.
Working with us
Yes. Many clients are manufacturers abroad entering Kenya and East Africa. Where a regulator requires a local representative, we can act as your Local Technical Representative.
A free 30-minute video call to understand your products, markets and deadlines. You leave with clear next steps, whether or not you work with us.
Yes. We provide qualified people for pharmacovigilance and run case processing, safety reporting and PSMF upkeep for you.
We work under NDA, limit access to the people on your project and handle personal data in line with the Kenya Data Protection Act 2019.
Yes. We run pharmacovigilance and regulatory affairs training online or at your premises, tailored to your products and markets.
No. The first 30-minute discovery call is free. Fees for any work are agreed in writing beforehand, and nothing is paid on this website.
Yes. We plan a handover so that no adverse event report or submission deadline is missed.
The Pharmacy and Poisons Board in Kenya, and the regulators of Uganda, Tanzania, Rwanda and Ethiopia. Other markets are possible on request.
Marketing authorisation holders report suspected adverse reactions and other safety information to the Pharmacy and Poisons Board, which runs an online reporting system (PvERS). We set up and run this reporting for you.
A local technical representative acts for a manufacturer based outside Kenya in dealings with the Pharmacy and Poisons Board, including registration and follow-up.