Our Pharmaceutical Regulatory Services
Regulatory Representation
We act as the official liaison between foreign companies and the Pharmacy and Poisons Board (PPB). We are duly registered with the Pharmacy and Poisons Board as:
- Local technical Representatives for Pharmaceutical products (LTR)
- Local Authorised Representative for Medical devices (LAR)
Our responsibilities include:
- Communicating with PPB on behalf of the client to ensure smooth regulatory processes
- Provide guidance on the regulatory landscape in the East African market.
- Submitting applications for product registrations, variations, renewals etc
Regulatory Affairs services
- Compiling and reviewing Common Technical Documents (CTDs) or other required formats of dossiers to ensure they all meet the Health Authority standards.
- Timely submission of registration dossiers of pharmaceutical products, medical devices, nutraceuticals, cosmetics and all other pharmaceutical related products within East Africa
- End-to-end registration process with regular follow ups, prompt response to Health Authorities’ queries to ensure timely market authorizations
- Lifecycle management of the above products with Health Authorities within East Africa through handling of retentions, renewals, Good Manufacturing Practices, variations etc.
- Import permit applications for both samples and commercial products
- Product labels, artwork, and packaging review to ensure compliance to meet the Health Authorities regulatory standards
Pharmacovigilance Services
We act as Qualified Person for Pharmacovigilance (QPPV) in Kenya. We help clients maintain compliance with Kenya’s safety monitoring requirements by:
- Monitoring and reporting Adverse Drug Reactions (ADRs)
- Establishing and maintaining a local pharmacovigilance system as required by PPB
- Submission of Individual Case Safety Reports (ICSR)s to NRAs
- Aggregate safety reporting (PBRER/PSUR/DSUR)
- Local Literature screening
Good Distribution Practice compliance and Quality Assurance for Distributors
Support in implementation and ensuring of compliance with WHO, EU & PPB GDP guidelines
Clinical Trials Applications
Support in preparation and submission of clinical trial applications to the relevant Health Authorities in East Africa.
