Dr. Mwiko Health Solutions Ltd acts as a trusted Local Technical Representative (LTR) for global pharmaceutical, biotechnology, and medical device companies seeking to establish or maintain a compliant presence in Kenya.
Our LTR services ensure that your products meet all local regulatory requirements while providing you with an experienced partner who represents your technical and regulatory interests before the Pharmacy and Poisons Board (PPB) and other national authorities.
Our Role as Your Local Technical Representative
As your designated LTR, we provide end-to-end regulatory and technical oversight to ensure continuous compliance, market access, and effective communication with local stakeholders. Our services include:
- Regulatory Liaison & Representation
Acting as the official point of contact with the PPB and other Kenyan regulatory bodies for all product-related communications, inspections, and updates.
- Dossier Management & Submissions
Supporting preparation, submission, and follow-up of registration dossiers, renewals, variations, and post-approval changes in accordance with Kenyan regulations and EAC harmonized guidelines.
- Pharmacovigilance & Safety Oversight
Ensuring local safety monitoring and compliance through coordination with the Local Qualified Person for Pharmacovigilance (LQPPV) and maintenance of safety documentation.
- Quality & GMP Compliance
Providing technical support for quality assurance, product release activities, and Good Manufacturing Practice (GMP) compliance, including audit coordination and CAPA follow-up.
- Importation & Distribution Support
Assisting with import permit applications, customs documentation, and coordination with local distributors to maintain an uninterrupted supply chain.
- Regulatory Intelligence & Updates
Continuous monitoring of regulatory developments in Kenya and across the East African Community (EAC) to keep your organization informed and compliant.
Why Choose Dr. Mwiko Health Solutions Ltd
- Recognized Expertise: We have deep experience in Kenyan and regional regulatory frameworks.
- Seamless Communication: We bridge the gap between your global teams and local authorities with accuracy and responsiveness.
- Compliance Assurance: We uphold the highest ethical and scientific standards to protect your product licenses and reputation.
- Scalable Partnership: Whether for a single product or an entire portfolio, we tailor our representation model to your operational needs.
At Dr. Mwiko Health Solutions, we go beyond regulatory representation, we become your in-country compliance partner, ensuring that your products remain safe, authorized, and available to patients across Kenya.
