Regulatory consulting, medicine registration and compliance support across South Africa.
Regulatory Expertise
SAHPRA & SADC specialists
End-to-End Support
From strategy to approval
Compliance Focused
ICH & GxP aligned
Trusted Industry Partners
Local & international sponsors
Regulatory Expertise
SAHPRA & SADC specialists
End-to-End Support
From strategy to approval
Compliance Focused
ICH & GxP aligned
Trusted Industry Partners
Local & international sponsors
0%
Compliance Focus
0/7
Client Support
End-to-End Regulatory Support
Industry Best Practices
Science-led regulatory practice
AFS Pharma is a specialist pharmaceutical regulatory consulting company dedicated to helping pharmaceutical organisations navigate complex regulatory environments with confidence.
A specialist pharmaceutical regulatory consulting company serving industry across South Africa.
Enabling organisations to reach market approval with clarity, speed and compliance.
Registration, CTD/eCTD dossiers, strategy and lifecycle management.
Rigorous, discreet and strategically driven engagements — every time.
Aligned to ICH, GxP and SAHPRA standards, supporting sponsors across SADC.
Corporate-grade governance, documentation quality and accountability.
Medicine Registration
Regulatory Compliance
CTD / eCTD Expertise
Regulatory Strategy
Lifecycle Management
Training & Advisory
Simplifying regulatory compliance so healthcare innovations reach patients safely.
To become one of Africa's leading pharmaceutical regulatory consultancies.
Integrity, excellence, innovation, partnership and transparency.
Experienced Specialists
Tailored Solutions
Regulatory Excellence
Fast Communication
Industry Expertise
Client-Focused Service
Pharmaceutical Manufacturers
Biotechnology Companies
Research Organisations
Medical Device Companies
Importers & Distributors
Emerging Businesses
Government Projects
International Sponsors
1Consultation
2Assessment
3Documentation
4Submission
5Authority Review
6Approval
7Lifecycle Support
1Consultation
2Assessment
3Documentation
4Submission
5Authority Review
6Approval
7Lifecycle Support
Working alongside respected organisations to strengthen pharmaceutical innovation, regulatory excellence and healthcare outcomes.
Strategic Partner
Centaro Biosciences is a biotechnology company focused on developing innovative medicines for unmet medical needs. Their scientific research and translational approach support the advancement of next-generation therapies and pharmaceutical innovation.
Visit WebsiteStrategic Partner
RxOptimise Solutions provides specialist pharmaceutical optimisation, formulary management and healthcare consulting services that improve clinical outcomes while reducing unnecessary healthcare expenditure.
Visit WebsitePartner with AFS Pharma to accelerate your regulatory journey.
Schedule a ConsultationHave a regulatory question or need support with your pharmaceutical product? Contact the AFS Pharma team directly.