Our Services
How can we help you? The Apex Advantage
1. Regulatory Affairs & SAHPRA Compliance
Navigating South Africa’s regulatory environment demands specialist knowledge and methodical execution. We manage the full regulatory lifecycle from initial dossier preparation through to post-registration compliance monitoring, so your team can focus on running your business. What we handle:
• SAHPRA new product registration and variation applications
• SAPC pharmacy licence applications and renewals • Strategic regulatory planning and submission timelines
• Post-market surveillance and regulatory reporting
• Labelling reviews and packaging compliance
• Product Lifecycle Management Every engagement begins with a compliance gap assessment.
We document the path forward, assign clear timelines, and deliver.
2. Formulation Development and Optimisation
Product success begins with the right formulation. We develop and optimise pharmaceutical, cosmetic, and food formulations that meet regulatory requirements, perform consistently, and hold up under stability conditions. What we deliver:
• Custom formulation design tailored to your target market and regulatory pathway
• Stability testing programs aligned to ICH and SAHPRA requirements
• Formulation optimisation for cost efficiency, patient compliance, or performance
• Technical dossier support for regulatory submissions
3. Quality Control Testing & Assurance
Your product’s credibility is built on the consistency of its quality. We implement quality assurance systems and testing protocols that satisfy SAHPRA requirements, meet international GMP standards, and protect your brand’s reputation in the market. What we provide:
• Analytical method development and validation • Batch testing and release protocols
• Quality Management System (QMS) design and implementation
• GMP gap assessments and remediation support
• Stability study design and monitoring
• Audit preparation and response support Quality is not a report you receive at the end of production.
It is a system we help you build into every step of your process.
