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Empowering Excellence, Ensuring Compliance
We take over the RA duties, allowing our clients to focus on the strategy and operations of their businesses.
Our services include:
SAHPRA Licensing (Medical Devices, Medicines & APIs)
New Product Registration Support
Section 21 Applications & Import Permits
Regulatory Due Diligence & Compliance Audits
Clinical Trial Applications
Our ISO 13485 consulting services are designed to help your company build a robust Quality Management System (QMS) and successfully pass third-party certification.
Our services include:
Gap Assessments & Readiness Reports
QMS Design: SOPs, Quality Manual, and Records
Internal Auditor Training (on-site or virtual)
Mock Certification Audits
Support in Selecting Accredited Certification Bodies
Ongoing QMS Maintenance & Improvement
Market Access Strategy (South Africa & SADC)
Business Process Optimization
Risk Management & Governance Consulting
Policy & SOP Development
Executive Compliance Coaching
We provide expert guidance on meeting regulatory requirements for medical devices, ensuring your products comply with SAHPRA and international standards.
Our services include:
Distribution Channel Compliance & Audits
Licensing for Wholesaling & Distribution
Technical Dossiers & Product Classification
Tender Support & Commercial Entry Strategy
We understand the importance of training in maintaining compliance and achieving operational excellence .
Our services include:
ISO 13485 Internal Auditing
Good Wholesaling Practice (GWP)
Regulatory Compliance 101
SAHPRA Licensing Preparation
Pharmacovigilance Training