Alpha CR Solutions manages the full regulatory and ethics submission lifecycle — from protocol development through SAHPRA approval, IRB and IEC submissions, to ongoing compliance.
CTAs, amendments and annual safety reports for South African trials.
NHREC-registered IRB and site IEC submissions across therapeutic areas.
ICH E6(R2) compliant training for investigators and site teams.
Source Data Review-first approach for data integrity from day one.
Navigating the South African regulatory and ethics landscape demands more than form-filling — it requires deep institutional knowledge, established relationships with health authorities, and a rigorous quality framework.
Our team integrates directly into your study operations, managing submissions to the South African Health Products Regulatory Authority (SAHPRA) and ethics committees registered with the National Health Research Ethics Council (NHREC).
Whether you are an emerging biotech conducting your first Phase I trial in South Africa, or a global sponsor expanding into Africa, we tailor our regulatory strategy to your timeline, budget, and therapeutic area.
Get in TouchAlpha CR Solutions manages every phase of the South African regulatory and ethics approval process — giving you a single point of accountability from submission to site activation.
Protocol & ICF Development
Study documents prepared to SAHPRA and ICH standards.
SAHPRA CTA Submission
Full CTA compiled including IMPD, IB and protocol synopsis.
IRB & IEC Submissions
Parallel submissions to NHREC IRBs and site IECs.
Dual Approval
Coordinating SAHPRA and ethics approvals simultaneously.
Site Initiation
GCP training, SDR setup and SIV support.
Ongoing Compliance
Amendments, annual reports and safety notifications.
Comprehensive support across the full spectrum of South African clinical trial regulatory requirements.
End-to-end management of all submissions to the South African Health Products Regulatory Authority.
Full lifecycle management of IRB and IEC submissions in compliance with NHREC requirements.
Experienced CRAs supporting sites from qualification through close-out to ICH E6(R2) standards.
Direct experience managing submissions across South African and international regulatory frameworks.