Our Expertise
We offer a wide range of services designed to ensure efficiency, safety, and compliance across the pharmaceutical supply chain.
Pharmaceutical Regulatory Affairs Solutions - Comprehensive regulatory support ensuring compliance and successful market authorization across East Africa.
Strategic guidance on registration for Health Products and Technologies (HPTs) across East Africa Community through various pathways.
Management of product renewals, retention, post-market surveillance, and variations to ensure ongoing compliance.
Expert assistance with the preparation and submission of applications for the East African Market, including query response support.
Facilitating the application and scheduling of site inspections and compliance audits for manufacturing facilities.
Facilitation in obtaining licensing and approvals for product advertisements and promotional materials.
Handling permit processing at regulatory authorities such as PPB, KEBS, and Kenya Revenue Authority.
Coordination of product sample submissions and follow-up for certification at pre-qualified labs.
Facilitating the availability of high-value prescription medicines and orphan drugs.
Legal entity setup, premises setup (retail/wholesale), and implementation of QMS systems and processes.
Setting up new manufacturing units or supporting expansion and compliance of existing facilities.
Comprehensive management of medical device registrations, intellectual property rights, and regulatory compliance within the pharmaceutical sector.
Cold Room Installation & Mapping, Safe and Secure Storage, Inventory Management, and Third-Party Logistics (3PL).
Flexible, cost-effective remote Regulatory Affairs services leveraging the latest technology.
Services for IMPs, Medical Devices, and Authorized Products post-Marketing Authorization.
Entry strategies, linking manufacturers with distributors, and HR facilitation.
Comprehensive support for all facets of Clinical Trial Applications (CTAs).
Licensed Kenyan clearing agency offering Import-of-Record (IOR), specialized customs clearing, cold-chain warehousing, and 3PL distribution for medical and pharmaceutical goods.
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