Dr. Mwiko Health Solutions Ltd offers a complete suite of Regulatory Affairs and Chemistry, Manufacturing and Controls (CMC) services to help organizations meet compliance requirements, achieve faster product approvals, and sustain long-term regulatory success.
Core Areas of Focus
- Regulatory and Clinical Strategy Development
We design submission and registration strategies tailored to your product and market goals, enabling efficient engagement with regulatory authorities from the development phase through to launch.
- Regulatory Submissions and Maintenance
We prepare, compile, and manage all types of applications, including variations, renewals, and authority responses in full compliance with CTD/eCTD standards.
- Chemistry, Manufacturing & Controls (CMC)
We support the preparation and review of CMC documentation to ensure manufacturing processes, specifications, and product quality meet regulatory and GMP requirements throughout the lifecycle.
- Clinical Trial Applications (IND/CTA)
We coordinate and submit investigational and clinical trial documentation to relevant ethics committees and health authorities, ensuring alignment with both global and African regulatory frameworks.
- Labeling and Product Information
Our team develops and harmonizes labeling content and patient information leaflets to maintain consistency, clarity, and regulatory accuracy across markets.
Why Partner with Us
- Local Knowledge, Global Standards: Deep understanding of African regulations combined with international best practices.
- Efficiency and Accuracy: Streamlined document management and proactive authority engagement shorten timelines and reduce risk.
- Flexible Collaboration Models: Scalable outsourcing and advisory solutions that adapt to client structures and regulatory complexity.
At Dr. Mwiko Health Solutions, we turn regulatory challenges into strategic opportunities. Our goal is to help you register, maintain, and expand your products with confidence, ensuring every submission meets the highest scientific and compliance standards.
