MRA Regulatory Consultants (Pty) Ltd. was established in 2003 to provide expert regulatory advisory services and regulatory support services to the healthcare products industry.
We enjoy a clear understanding of the regulatory environment in South Africa, its history, trends, current requirements and policies. We are associate members of many of the industry associations and in our professional capacities affiliated to the professional associations. These associations, together with networks we have nurtured, provide us with current information related to the health products industry.
Our Mission: To provide the most sought-after quality, value-based, expert service offering in the regulatory, legislative and GxP compliance environments for the pharmaceutical and healthcare products industry [including: Medicines, Medical Devices | IVDs, Complementary Medicines | Health Supplements] for human and animal use, in South Africa and Africa.
We use the most up to date software solutions to enable us to compile and publish eCTDs and paper CTDs. We are able to manage the life-cycle of regulatory information, thus maintaining registration documents in a fully validated electronic document management system.
We aim to empower our customers with the knowledge and understanding of the regulatory and compliance environment related to their products. This enables informed decision making and sustainable compliance strategies to be developed and implemented.