Insights IQ

Registration, pharmacovigilance and LTR through partners

Regulatory affairs

Registration dossiers, Local Technical Representative arrangements through licensed partners, and pharmacovigilance in Kenya.

We prepare and file registration dossiers with the Pharmacy and Poisons Board, arrange Local Technical Representative services for foreign marketing authorisation holders through licensed partners, and run pharmacovigilance, the collection and reporting of side effects. A named pharmacist owns your file, and nothing is filed without your sign-off.

Questions

Questions we are asked.

Can you arrange a Local Technical Representative in Kenya?

Yes. We arrange one through a licensed partner and coordinate the correspondence, safety reporting, recalls and inspections the role carries.

Do you run pharmacovigilance without a patient support programme?

Yes; we offer it to any sponsor, whether or not we run its programme.

Entering or growing in an African healthcare market?

Tell us the market, the product or the programme. We reply within two working days with how we would approach it and what it would take.