Regulatory & Compliance Advisory
Navigate FDA, EFDA, and WHO expectations with clear regulatory mapping, compliance readiness, and governance support.
Calebyte BioSolutions
Regulatory & Ethics Support
Regulatory strategy, submissions, and ethics committee coordination that keep your study compliant and participants protected.
Overview
About Regulatory & Ethics Support
Clinical studies in Africa require approvals from national regulatory authorities and ethics committees, each with its own requirements and timelines. Navigating these well is essential to both study timelines and participant protection.
We help sponsors plan regulatory and ethics pathways, prepare high-quality submissions, and coordinate with review bodies throughout the life of the study, while strengthening research governance at participating institutions.
Challenges addressed
The problems we help you solve
Multiple review bodies
National authorities, institutional review boards, and ethics committees with differing processes.
Submission quality
Incomplete or poorly adapted dossiers that lead to queries and delays.
Ongoing obligations
Amendments, safety reports, and renewals that must be managed throughout the study.
Governance gaps
Institutions that need stronger oversight structures for sponsored research.
Capabilities
How we support you
Specialized support across the full scope of Regulatory & Ethics Support.
Regulatory strategy
Plan the regulatory pathway, sequencing, and timelines for your study.
Regulatory submissions
Prepare and adapt submission packages for national regulatory authorities.
Ethics committee coordination
Manage interactions, queries, and approvals with ethics committees.
IRB support
Prepare protocols, consent forms, and supporting materials for IRB review.
Compliance readiness
Prepare sites and teams for inspections, audits, and ongoing compliance.
Research governance
Strengthen oversight structures, policies, and accountability for research.
Our approach
A structured, collaborative process
- 1
Plan
Map regulatory and ethics requirements for each site.
- 2
Prepare
Develop complete, locally adapted submission packages.
- 3
Coordinate
Manage review, queries, and approvals with each body.
- 4
Maintain
Handle amendments, renewals, and ongoing reporting.
Benefits
What you can expect
Fewer review cycles
Submissions prepared for local expectations.
Protected participants
Ethics oversight built into study design.
Inspection readiness
Teams and documents prepared for scrutiny.
Stronger institutions
Governance that supports future research.
Related services
Explore related services
Clinical Trial Services
End-to-end operational support from feasibility and site identification through study start-up, monitoring, and coordination.
Pharmacovigilance
Safety reporting, adverse event documentation, and pharmacovigilance processes that protect participants and meet reporting obligations.
Planning a clinical study in Africa?
Tell us about your goals and we will help you identify the right next step.