Professional Compliance & Quality Management Services
Tailored Solutions For Pharmaceutical & Medical Device Businesses
Our services are designed to help organisations establish, maintain and improve quality management systems aligned with ISO standards and SAHPRA regulatory requirements.
ISO 13485 Gap Analysis
We perform detailed assessments of your current systems against ISO 13485:2016 requirements and relevant SAHPRA guidelines.
What's included?
- Clause-by-clause evaluations
- Documentation reviews
- Risk identification
- Prioritised action plans
- Compliance readiness assessments
ISO 13485 Requirements Training
Interactive virtual and in-person training sessions designed to help teams understand how ISO 13485 requirements apply to their business operations and products.
Training Covers
- Quality management principles
- Documentation requirements
- Risk management
- SAHPRA expectations
- Compliance responsibilities
ISO 13485 Implementation
We provide complete step-by-step support to build and implement effective quality management systems aligned with international standards and local regulatory requirements.
What's Included?
- QMS development
- SOP creation
- Risk management systems
- Process mapping
- Compliance documentation
- Staff guidance and support
Independent Internal Audits
Professional independent internal audits conducted by a certified lead auditor for: ISO 13485, ISO 9001, GMP, GDP
Benefits
- Objective audit findings
- Comprehensive audit reports
- Corrective action guidance
- Improved compliance readiness
SAHPRA Licence Assistance
We assist businesses with SAHPRA licence applications, renewals and supporting documentation to simplify the process and improve compliance outcomes.
Need A Custom Compliance Solution?
- IRCA & CQI Certified Lead Auditor
- Over 15 Years Industry Experience
- More Than 40 Certification Audits Completed
- Practical Compliance Solutions
- SAHPRA Regulatory Expertise
- Tailored Support For Startups & Established Companies
- Professional & Independent Auditing Services