About Us
The company is run by a qualified pharmacist who has experience and qualifications in the pharmaceutical regulatory industry. She had the opportunity to serve in the South African Health Products Regulatory Authority in 2017-2018 in the inspectorate and law enforcement unit. Her key role in company was to serve as a control officer for the medical device unit. Within this unit, she was exposed to medical device establishment licences, product registrations, guideline formulations and served on the medical device committee. Along with a passion for pharmacy, her excellent work ethic has successfully encouraged her to endeavour in a business for the sole purpose of regulatory work. In her career as a pharmacist, she has experience in hospital, retail and regulatory pharmacy.
Our Aim
The aim of HPRC is to ensure that all medical companies in South Africa are compliant with the regulators within the medical industry as well as to guide these companies to international compliance with the International Standards (ISO 9001; ISO 13485). HPRC aims to achieve this goal by providing affordable consultations and assistance to the industry.
Our Vision
HPRC envisions that all health products trading on the South African market are safe and affordable to citizens of the Republic. Thus, with a strong regulatory oversight this will be achievable. HPRC will readily assist any pharmaceutical or medical company to gain regulatory insight ensuring that the output is favourable to the company and public.
10
Years of experience
10000
Cups of Coffee
500
Meetings
Introduction to the company
Our History
The Department of Health, Radiation Control (Department of Health) and the South African Health Products Regulatory Authority publishes various regulations and amendments to the Medicines and Related Substance Act, No. 101 of 1965 (as amended) which requires compliance from companies in South Africa. In order for all medical/ pharmaceutical companies to trade legally and appropriately in the Republic of South Africa, they are required to attain certifications and accreditations from various statutory bodies. The law of the Republic can be challenging for companies to comply with thus it became evident that the medical industry is in need of a regulatory consulting company whom can provide guidance and support companies with compliance. Thus in sight of the above Health Products Regulatory Consulting (Pty) Ltd (HPRC) was formed to assist medical and pharmaceutical companies to register with statutory bodies within South Africa.