Transforming Healthcare Through Expert Consulting
Afrikonsult delivers tailored solutions for medical device and pharmaceutical compliance in South Africa.
OUR SERVICES
Afrikonsult provide specialised consulting services for the medical device and pharmaceutical industries, ensuring compliance and operational excellence for our clients.
Our tailored solutions help you navigate regulatory requirements and achieve your business goals. We specialise in the following service categories:
Medical Devices
Medical Devices
Comprehensive support to achieve and maintain ISO 13485 certification for medical device quality management systems.
ISO 13485 GAP Analysis
Detailed assessments to identify compliance gaps and provide actionable recommendations.
Mediclinic Product Applications
Expert assistance with product applications for Mediclinic and other healthcare providers.
Certification Audit Preparation & Responses
Provide guidance through certification audits, assist with corrective action plans and responses.
Pharmaceutical
License Applications
(GMP, GWP, GDP):
Streamlined support for Good Manufacturing, Warehousing, and Distribution Practice licenses with SAHPRA.
SAHPRA Queries
Preparation and submission of responses to South African Health Products Regulatory Authority queries.
General
Consulting Services
Consulting
Customised strategies to optimise operations and ensure regulatory compliance.
Internal Audits
Thorough audits to assess compliance with industry standards and prepare for external inspections.
Quality Documentation
Compilation and review of Quality Manuals, Pharmaceutical Quality System (PQS) Manuals, and Site Master Files.
NAPPI Code Applications
Assistance with National Pharmaceutical Product Index (NAPPI) code applications for product registration.
Bespoke Consulting Solutions
Tailored advisory services to address unique project needs.
ABOUT US
INTRODUCTION
Welcome to Afrikonsult, your trusted partner in medical and pharmaceutical consulting.
Based in Pretoria, South Africa, we specialise in helping organisations navigate complex regulatory landscapes, optimise operations and achieve compliance with industry standards. Our mission is to deliver tailored solutions that reduce workload, enhance efficiency, and create a positive work environment for your team.
Our Expertise
With a combined experience of over 28 years in pharmaceuticals, medical devices and engineering, our leadership team brings unparalleled expertise to every project.
We are committed to excellence, ensuring your organisation meets statutory and regulatory requirements while driving operational success.
LEADERSHIP TEAM
Director & Lead Consultant
Marelize is a seasoned Pharmacist with over 13 years of experience in the pharmaceutical and medical device sectors. Her expertise spans retail pharmacy, production, quality assurance and regulatory affairs, with a proven track record of guiding clients through complex compliance processes. Marelize has successfully led ISO 13485 implementations, SAHPRA license applications and quality system development for numerous organisations. Her client-centric approach ensures practical, tailored solutions that align with your business goals.
Director of Operations
Dylan is a Professional Transport Engineer with over 15 years of experience in civil engineering, specialising in project management, regulatory compliance and operational optimisation across Southern Africa. Having overseen numerous construction projects, Dylan brings a wealth of expertise in contract administration, technical specifications, stakeholder liaison and dispute resolution. Dylan leverages his analytical skills and strategic problem-solving to streamline operations, ensuring regulatory alignment and client success in the medical and pharmaceutical sectors.
Contact Us
+27 72 929 6563 | marelize@afrikonsult.co.za
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