MRA Regulatory Consultants
We are a team of experienced and knowledgeable regulatory consultants committed to bringing quality medicines to South Africa
MRA Regulatory Consultants (Pty) Ltd. was established in 2003 to provide expert regulatory advisory and support services to the Health Products industry.
We enjoy a clear understanding of the regulatory environment for Health Products 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 the networks we have nurtured, and our information gathering systems, keep us abreast of developments and the current status of the health products industry.
We use up to date software solutions to enable us to compile and publish eCTDs and hard-copy applications. We are able to manage the life-cycle of regulatory information, thus maintaining registration and other compliance 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, implemented and maintained.
To provide the most sought-after quality, value-based expert service offerings in the regulatory and GxP compliance environment for the pharmaceutical and healthcare products industry, including: medicines, medical devices, complementary medicines and health supplements, for human and animal use, in South Africa.