Comprehensive Pharmaceutical Solutions
From regulatory compliance to market intelligence, we deliver end-to-end solutions that empower pharmaceutical companies to thrive across South Africa and the SADC region.
Regulatory Affairs & Market Access
Regulatory Affairs Services
Providing leading regulatory affairs services and drug registration services in South Africa and the SADC region. We streamline your regulatory submission services and dossier compilations to ensure swift health agency approvals.
Medical Device Registration
Expert regulatory pathways, device classifications, and SAHPRA registration support for medical devices, IVDs, and health technology products. We ensure comprehensive compliance with local safety and quality metrics.
Import Permits
Facilitating import permits for pharmaceutical drugs and active substances in South Africa. We oversee custom clearance protocols, border documentation, and SAHPRA import license verification.
Healthcare Regulatory Consulting
Strategic healthcare regulatory consulting in South Africa, providing market intelligence, pricing studies, dossier gap reviews, and harmonized SADC entry pathways for global pharmaceutical companies.
Registration Planning
Strategic guidance on registration for Health Products and Technologies (HPTs) across South Africa and the SADC region through various regulatory pathways.
Product Lifecycle Management
Management of product renewals, retention, post-market surveillance, and variations to ensure ongoing compliance throughout your product's market life.
Marketing Authorization
Expert assistance with the preparation and submission of applications for the South African and regional markets, including comprehensive query response support.
Compliance & Quality Management
GMP Audit Services
Comprehensive GMP audit services and GMP compliance consulting in South Africa. We help prepare manufacturing sites, packaging operations, and laboratories for local health agency licensing.
Audit & Gap Analysis
Leading pharmaceutical audit consultancy services offering independent third-party mock audits, quality risk management setups, and GMP/GDP gap assessments to verify compliance.
Quality Assurance Pharma
High-end quality assurance services and pharmaceutical compliance audits in South Africa, detailing Standard Operating Procedures (SOPs), validation processes, and QMS implementation.
Pharmaceutical Licensing
Guiding pharmaceutical licensing processes in South Africa. We assist with facility setup approvals, manufacturing audits, and regulatory licensing clearances for distribution houses and laboratories.
Manufacturing Site Setups
Setting up new manufacturing units or supporting expansion and compliance of existing facilities with full regulatory guidance and quality system implementation.
Pharmaceutical Company Setup
Complete legal entity setup, premises establishment (retail/wholesale), and implementation of Quality Management Systems (QMS) and operational processes.
Clinical Trials & Safety Operations
Clinical Trials
End-to-end clinical trial regulatory approval pathways in South Africa and SADC. We navigate trial applications, protocol submissions, ethics clearance committees, and local trials logistics.
Pharmacovigilance Services
State-of-the-art pharmacovigilance services in South Africa, adverse event reporting systems, and SAHPRA risk management compliance, ensuring continuous safety monitoring.
Warehousing & Storage
Temperature-controlled storage solutions fully compliant with Good Distribution Practice (GDP) standards. We audit cold chain setups, validation parameters, and ambient storage logs.
Clinical Trial Applications
Comprehensive support for all facets of Clinical Trial Applications (CTAs), from protocol submissions to ethics committee approvals throughout South Africa and SADC.
Specialized Services
HPTs Advertisement
Facilitation in obtaining licensing and approvals for product advertisements and promotional materials to ensure compliance with regulatory advertising standards.
Laboratory Analysis Support
Coordination of product sample submissions and follow-up for certification at pre-qualified laboratories, ensuring accurate and timely analytical results.
Sourcing of Medicine
Facilitating the availability of high-value prescription medicines and orphan drugs through our extensive network of trusted global suppliers.
Intellectual Property
Comprehensive management of intellectual property rights within the pharmaceutical sector, including patent guidance and trademark protection strategies.
Remote RA Services
Flexible, cost-effective remote Regulatory Affairs services leveraging the latest technology to support your regulatory needs from anywhere in the world.
Clearing and Forwarding Coming Soon
Expert clearing and forwarding services specialized for health products and technology. Coming soon — streamlined customs and logistics solutions.
How We Work
Consultation
Understanding your needs and SADC regulatory challenges.
Strategy
Developing tailored regulatory and compliance pathways.
Execution
Submitting, auditing, and executing strategies with precision.
Support
Ongoing lifecycle maintenance for continued compliance.
