Regulatory Consulting · Licensing · Supply Brokerage
Your regulatory partner for market access across Southern Africa
AcsysPharma helps pharmaceutical manufacturers, distributors and institutions navigate product registration, licensing and supply across nine SADC markets — backed by over 20 years of hands-on regulatory affairs experience and direct engagement with the region's national regulators.
Practice Snapshot
- Regulatory affairs experience
- 20+ yrs
- CTD / eCTD dossiers authored
- 100+
- SADC countries covered
- 9
- Active distributor markets
- 6
What we do
Three ways we get products to patients
Regulatory Strategy & Registration
Bespoke SADC market-entry strategy, full dossier authoring and lifecycle management, and submission coordination with SAHPRA, MCAZ, BoMRA, ZAMRA and NMRC.
See our servicesThe ZAZIBONA Centralised Procedure
One centralised joint scientific assessment, recognised by the Active Member States of the SADC region, for expedited national registration.
Understand ZAZIBONALicensing & Supply Brokerage
Direct distributor relationships across six focal SADC markets, connecting specialised European manufacturers to the patients who need them.
View our footprintWe work directly with SAHPRA (South Africa) · MCAZ (Zimbabwe) · BoMRA (Botswana) · ZAMRA (Zambia) · NMRC (Namibia) · ZAZIBONA
Why AcsysPharma
Depth of a consortium, speed of a specialist
A consortium, not a generalist
A network of pharmaceutical, business and technical consultants spans product development, technology transfer, dossier authoring and audit — so clients get specialist depth at every stage.
Regulator-facing, not just paper-facing
Direct, ongoing engagement with national regulatory authorities means query response and deficiency management move faster because the relationships already exist.
Built in the region, based in Europe
Leuven, Belgium places us close to the manufacturers behind Europe's specialised medicines — with the SADC regulatory and distributor network to get them registered and supplied.
Ready to move a product toward registration in Southern Africa?
Whether you need a full SADC market-entry strategy, hands-on dossier management, or a partner with distributor relationships already in place — let's talk about where you are today.
About Us
An independent practice built on regulatory depth
AcsysPharma is an independent regulatory consulting practice founded to manage pharmaceutical product registration across the SADC region — now expanding into licensing and supply brokerage to help close a persistent gap in access to specialised medicines across Southern Africa.
AcsysPharma brings together extensive, practical knowledge of national registration processes across the SADC region and direct engagement with national drug regulatory authorities (NDRAs). We operate as a consortium of pharmaceutical, business and technical consultants, with expertise spanning:
- Product development
- Technology transfer projects
- Dossier authoring
- Dossier review & evaluation
- Pre-inspection audits
- Vendor audits
- Regulatory authority engagement across most SADC countries
- The ZAZIBONA Centralised Procedure
This breadth means a client's product moves through registration with the right specialist at each stage — rather than being handled by a single generalist advisor.
Stage 01
Regulatory Consulting
Founded to manage product registration across the ZAZIBONA region for international manufacturers.
Stage 02
Licensing Expertise
Deep regulatory intelligence became the foundation for structuring licensing agreements.
Stage 03
Supply Brokerage
Diversified into brokering supply, underpinned by established distributor relationships.
Stage 04
Critical Care Focus
Sourcing specialised European medicines currently unavailable in parts of Southern Africa.
AcsysPharma currently operates as an independent consulting practice. Formal registration as a company in Belgium is under way.
Givemore Mushayi
Founder & Principal Consultant
A pharmaceutical scientist and regulatory affairs specialist with over 20 years of hands-on experience across product development, regulatory submissions and quality assurance. Recognised as a specialist for both SAHPRA and the ZAZIBONA Centralised Procedure, with a working footprint across nine SADC countries.
Career spans Principal Consultant at AcsysPharma, Group Head of Regulatory Affairs at Avacare Health Group, and Technical Specialist at Innovata Pharmaceuticals — authoring more than 100 CTD/eCTD dossiers for SAHPRA, SADC regulators and WHO Prequalification (WHO-PQ).
Active Member — SAPRAAServices
Five integrated service lines
Engage each independently, or combine them into a full registration and market-access programme.
01 · Regulatory Strategy
A bespoke market-entry strategy built around your actual product portfolio.- Assessment of your product portfolio against SADC market opportunity
- Dossier readiness assessment — what's submission-ready today, and what isn't
- Product development strategy tailored to SADC regulatory requirements
- Submission pathway recommendation — national route vs. ZAZIBONA
- A technical package of guidelines and processes, market by market
02 · Product Registration — Managed Services
End-to-end management of your submissions and their full lifecycle.- Coordination of multi-country submissions across focal & secondary SADC markets
- Lifecycle management — submissions, query-response, certification, due-date tracking
- Dossier screening & gap analysis for national submissions to SAHPRA, MCAZ, BoMRA and others
- Full compilation in CTD / eCTD format, Modules 1–5
- Authoring of QOS, Clinical Summaries and BTIF documentation
NDRA review management
- Query review and gap analysis
- Compilation of responses to national regulatory authorities
03 · Supplier & Vendor Management
Confidence in who you source from and supply through.- Maintenance of a supplier / vendor GMP database
- Vendor audits and evaluation
04 · GMP Support
Practical, inspection-ready support — from upgrade advice to pre-inspection audits.- Plant upgrade review against SADC regulatory requirements
- Pre-inspection audits ahead of SAHPRA, WHO-PQ and ZAZIBONA inspections
05 · Training & Team Development
Bespoke training that builds your team's own regulatory capability.- Tailored training on the scientific requirements behind dossier compilation, built around your team's gaps and portfolio
ZAZIBONA Centralised Procedure
One centralised assessment, recognised across the SADC region
The ZAZIBONA Centralised Procedure (ZAZIBONA CP) is the joint scientific assessment pathway of the SADC Medicines Regulatory Harmonisation programme. All 16 SADC Member States participate — as Active, Non-Active or Observer states, according to their own assessment and cGMP-inspection capacity — with a single joint dossier review standing in for separate submissions to each national regulator.
Dossiers are submitted once, centrally, and assessed by a shared pool of regulator-seconded reviewers. Applicants using the CP should not lodge the same product with individual Member States in parallel — the two pathways are mutually exclusive, to avoid duplicated review.
The output is a written scientific recommendation rather than a registration in itself. A positive recommendation entitles the applicant to expedited national review by the participating Active Member States.
ZAZIBONA accepts new products through periodic Expression-of-Interest calls, each with its own eligibility scope and submission windows. AcsysPharma tracks each call and prepares client dossiers ahead of time, so they're ready the moment applications reopen. Contact us for the current status.
How AcsysPharma manages the process
- Portfolio screening against current ZAZIBONA eligibility and disease-area scope
- Timing and preparation of the Pre-Submission Form ahead of the next EOI window
- Full CTD dossier gap analysis and compilation to ZAZIBONA CP requirements, including QOS and BTIF
- Management through screening, the joint assessment session, and query-response cycles
- Preparation of the updated master dossier for expedited national registration once a positive recommendation is issued
Regional Footprint
Nine SADC countries, six active distributor relationships
Beyond regulatory work, AcsysPharma has built direct distributor relationships across Southern Africa — the network underpinning our supply brokerage capability.
| Market | Status | Relationship |
|---|---|---|
| South Africa | Focal | Active distributor relationship |
| Zimbabwe | Focal | Active distributor relationship |
| Zambia | Focal | Active distributor relationship |
| Botswana | Focal | Active distributor relationship |
| Namibia | Focal | Active distributor relationship |
| Lesotho | Focal | Active distributor relationship |
| Malawi | Secondary | ZAZIBONA joint-assessment reach |
| Tanzania | Secondary | ZAZIBONA joint-assessment reach |
| Eswatini | Secondary | ZAZIBONA joint-assessment reach |
Regulators we engage directly
- SAHPRA — South African Health Products Regulatory Authority
- MCAZ — Medicines Control Authority of Zimbabwe
- BoMRA — Botswana Medicines Regulatory Authority
- ZAMRA — Zambia Medicines Regulatory Authority
- NMRC — Namibia Medicines Regulatory Council
- ZAZIBONA — SADC MRH Centralised Joint Assessment Procedure
Contact
Let's talk about your market access in Southern Africa
Tell us about your product, your target markets, and where you are in the registration process — we'll follow up to discuss the right next step.
- Address
- Koning Leopold I Straat
3000 Leuven, Belgium - info@acsyspharma.be
- Phone — Belgium
- +32 467 61 91 04
- Phone — South Africa
- +27 76 685 6661