Services

Regulatory concierge services

  • Welcome to AfriLeadTech, your trusted partner for regulatory support services in South Africa. As a leader in regulatory knowledge, we offer comprehensive assistance to clients worldwide who are planning to conduct clinical trials in South Africa
  • By partnering with us, you gain access to a dedicated team of regulatory experts who act as your personal assistant, providing round-the-clock support throughout your project.

Unlock the Benefits of AfriLeadTech's Regulatory Support Services:


  • Early Regulatory Guidance: As a sponsor or applicant outside South Africa, utilizing our regulatory support services allows
    you to gain invaluable guidance and expertise before committing to Clinical Research Organizations (CROs) for your study.
    This proactive approach helps you make informed decisions, ensuring regulatory compliance from the outset and minimizing costly delays or setbacks.
  • Enhanced Efficiency: With AfriLeadTech’s support, you can streamline your regulatory processes and timelines.
    Our experienced team handles the intricate regulatory requirements, documentation, and communication with authorities,
    saving you time and effort. By leveraging our expertise, you can accelerate the initiation and progress of your clinical trial in South Africa.

  • Cost-Effective Solutions: By engaging AfriLeadTech for regulatory support, you can optimize your financing models.
    Our services provide a more affordable alternative compared to partnering with CROs for regulatory assistance.
    You can efficiently allocate your resources while still receiving high-quality regulatory expertise tailored to your specific needs.

Regulatory and EC Services

Regulatory Submission

  • SAHPRA consultation meetings prior to submission
  • Initial Protocol submission
  • Protocol Amendment submission support
  • Site changes support
  • Safety reporting
  • Progress reports submission
  • MTAs and Export permits
  • Regulatory guideline clarifications
  • Maintenance of SANCTR

Ethics  Submission

  • Informed consent customization

ICF customization as per EC (IEC &IRBs) requirements.

EC application process for initial and follow up protocol changes:  Experienced with all EC’s and IRBs in South Africa.

  • Reapprovals management
  • Safety reporting
  • Other EC submission

Partner with AfriLeadTech and experience the peace of mind that comes with having a dedicated regulatory support service by your side throughout your clinical trial journey in South Africa. Contact us today to discuss how we can assist you in achieving regulatory success.