it’s about impact.
We turn regulatory complexity into sustainable operational and market advantage.
Years of Experience
Regulatory & quality frameworks
Expert-driven delivery
What We Offer
End-to-end expertise helping clients meet global standards and achieve operational excellence.
Regulatory Affairs
We simplify regulatory pathways and submissions, supporting medicine registration, CTD dossier compilation, and full alignment with SAHPRA and international authorities.
Quality and Compliance
We build robust quality management systems and prepare organisations for successful GMP, GDP, GCP, and ISO-aligned audits.
Clinical Trial Operations
We strengthen clinical supply chains through efficient import and export permits, vendor oversight, and cold-chain control.
Pharmacovigilance & Safety
We design compliant PV systems and provide local QPPV-equivalent oversight, governance, and inspection readiness support.
Training & Capacity Building
We build internal capability through regulatory training, leadership development, and practical compliance education.
Strategic Advisory & Consulting
We support governance, process optimisation, and market access strategies that enable sustainable, compliant growth.
We partner with organisations to build systems that enable trust, scale, and lasting impact.
A Different Standard
Why Partner With GH Strategies
Chosen by organisations that value credibility, clarity, and long-term performance in regulated markets.
Credible Leadership
Work with experts trusted for judgment, discretion, and regulatory depth.
Built-to-Last Systems
Operational frameworks designed to perform today and endure as you grow
True Partnership
Expert-level engagement focused on outcomes, not templates or checklists.
What clients say about us
A few words from teams we have supported.
Regulatory Affairs Director
Pharmaceutical Company
We required local pharmacovigilance support. The PV Specialists from GH Strategies provided practical oversight, supported our reporting obligations, and helped our QPPV meet local regulatory requirements.
Responsible Pharmacist
Licensed Pharmaceutical Wholesaler
GH Strategies made the licensing process clear and practical, helping us set things up properly from the start. They also supported the setup of our QMS and the development of SOPs.
Managing Director
Medical Device Company
The Principal Consultant helped us secure our SAHPRA establishment licence and then guided the ISO 13485 implementation process, resulting in a structured system aligned with our operations.
From the Newsroom
Launching the GH Strategies Institute: Empowering Pharma and MedTech Professionals Through e-Learning
There are moments in every industry when progress demands a new way of thinking. For…
Strengthening Pharmacovigilance Systems: GH Strategies’ Vision for Safer Healthcare
Every medicine, vaccine, and medical device carries the promise of better health, but also the…
SAHPRA Requires ISO 13485 Certification for Medical Device Establishment Licences in South Africa
In April 2025, the South African Health Products Regulatory Authority (SAHPRA) formally announced that medical…
Optimising the Clinical Supply Chain: GH Strategies’ Role in Global Trial Readiness from South Africa
Clinical trials depend on precision – not only in research design but also in how…