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Regulatory & Ethical Support

Master your regulatory and ethical procedures in Francophone Africa

AFCRA assists in the preparation, submission and monitoring of regulatory and ethical files in order to secure authorizations and ensure the compliance of clinical trials with local and international requirements.

Definition
What is regulatory & ethical support?

A structured and pragmatic support system aimed at mastering regulatory and ethical requirements, reduce validation times and limit the risks associated with the local specificities of clinical research projects.

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Sponsors

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CROs

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Investigation sites

Our interventions
What we are doing in concrete terms
Preparation, review and submission of regulatory and ethical files
Submissions to the relevant Health Authorities and Ethics Committees
Monitoring of questions, requests for additional information and responses to authorities
Verification of documentary compliance (protocol, IB, consents)
Management and monitoring of regulatory and ethical amendments
Advice on deadlines, specific requirements and best practices by country
Results
What you get
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Complete and compliant files

Regulatory and ethical files prepared according to local and international requirements.

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Better controlled deadlines

Anticipating local requirements to reduce back-and-forth with authorities.

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Reduced regulatory risks

Fewer negative responses or requests for major additional information from the authorities.

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Secure Start

Securing the start and smooth running of clinical studies from the implementation phase.

Benefits
What you gain with AFCRA

🏦 Sponsors & CROs

  • ✅ Fewer negative reviews or requests for major additions
  • ✅ Realistic visibility on implementation timelines
  • ✅ Saves time on local regulations that are sometimes little known

🏥 Investigation sites

  • ✅ Files are better prepared and submitted on time
  • ✅ Better understanding of local regulatory requirements
  • ✅ Reduced stress associated with complex administrative procedures
Our other services
Complete your support
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Site Management SMO

Operational management and structuring of investigation sites.

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Clinical Research Training

Practical training adapted to the French-speaking African context.

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Availability & Opportunities

Qualified resources mobilized according to your field needs.

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Need regulatory and ethical support in Francophone Africa?

Contact us to discuss your needs and define a suitable support plan.