Navigating Compliance. Accelerating Access
At InSight Health Clinical, we help research sponsors and product developers confidently navigate the complex regulatory landscape across Africa. Our Regulatory & Market Entry Services ensure that clinical trials and health innovations move forward without unnecessary delays, meeting local, regional, and global requirements with precision.
From ethics board submissions to full product registration, we act as your compliance partner, bridging global strategy with in-country regulatory insight.
What We Offer
Ethics & Regulatory Submissions
We prepare and submit documentation for national and institutional review boards, helping you meet compliance requirements with clarity and completeness.
Regulatory Dossier Preparation
Our team compiles and formats technical dossiers for pharmaceuticals, diagnostics, and medical devices, aligned with country-specific requirements and WHO guidance.
Agency Liaison & Approval Tracking
We engage with regulatory authorities on your behalf, clarifying expectations, accelerating responses, and troubleshooting bottlenecks before they derail timelines.
Multi-Country Registration Support
Whether launching in one country or across the continent, we coordinate cross-border market entry plans with harmonized documentation and sequencing.
Strategic Regulatory Advice
From clinical trial planning to commercial launch, we advise sponsors on regulatory strategy, risk mitigation, and post-market surveillance obligations.