{"id":8789,"date":"2026-05-14T00:01:11","date_gmt":"2026-05-14T00:01:11","guid":{"rendered":"https:\/\/diis7880.odns.fr\/?page_id=8789"},"modified":"2026-06-04T23:25:29","modified_gmt":"2026-06-04T23:25:29","slug":"support-reglementaire","status":"publish","type":"page","link":"https:\/\/afcra-smo.org\/en\/services\/support-reglementaire\/","title":{"rendered":"Regulatory & Ethics Support"},"content":{"rendered":"
\n
<\/div>\n
<\/div>\n
\n \"Logo\n
Regulatory & Ethical Support<\/div>\n

Master your regulatory and ethical procedures in Francophone Africa<\/h1>\n

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.<\/p>\n

\n Contact us<\/a>\n All our services<\/a>\n <\/div>\n <\/div>\n<\/div>\n\n\n\n
\n Definition<\/span>\n
What is regulatory & ethical support?<\/div>\n
\n

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

\n
\n
\ud83c\udfe6<\/div>\n

Sponsors<\/h3>\n <\/div>\n
\n
\ud83d\udd2c<\/div>\n

CROs<\/h3>\n <\/div>\n
\n
\ud83c\udfe5<\/div>\n

Investigation sites<\/h3>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n\n\n
\n Our interventions<\/span>\n
What we are doing in concrete terms<\/div>\n
\n
\n \u2705<\/span>\n Preparation, review and submission of regulatory and ethical files<\/span>\n <\/div>\n
\n \u2705<\/span>\n Submissions to the relevant Health Authorities and Ethics Committees<\/span>\n <\/div>\n
\n \u2705<\/span>\n Monitoring of questions, requests for additional information and responses to authorities<\/span>\n <\/div>\n
\n \u2705<\/span>\n Verification of documentary compliance (protocol, IB, consents)<\/span>\n <\/div>\n
\n \u2705<\/span>\n Management and monitoring of regulatory and ethical amendments<\/span>\n <\/div>\n
\n \u2705<\/span>\n Advice on deadlines, specific requirements and best practices by country<\/span>\n <\/div>\n <\/div>\n<\/div>\n\n\n\n
\n Results<\/span>\n
What you get<\/div>\n
\n
\n
\ud83d\udcc1<\/div>\n

Complete and compliant files<\/h3>\n

Regulatory and ethical files prepared according to local and international requirements.<\/p>\n <\/div>\n

\n
\u23f1\ufe0f<\/div>\n

Better controlled deadlines<\/h3>\n

Anticipating local requirements to reduce back-and-forth with authorities.<\/p>\n <\/div>\n

\n
\ud83d\udee1\ufe0f<\/div>\n

Reduced regulatory risks<\/h3>\n

Fewer negative responses or requests for major additional information from the authorities.<\/p>\n <\/div>\n

\n
\ud83d\ude80<\/div>\n

Secure Start<\/h3>\n

Securing the start and smooth running of clinical studies from the implementation phase.<\/p>\n <\/div>\n <\/div>\n<\/div>\n\n\n\n

\n Benefits<\/span>\n
What you gain with AFCRA<\/div>\n
\n\n
\n
\n

\ud83c\udfe6 Sponsors & CROs<\/h3>\n