About us:
EL3M Consulting Services is a wholly black- owned Quality Management Systems consulting company that focuses on assisting both private and public healthcare institutions to achieve a certified ISO 9001:2015 Quality Management System, Regulatory Compliance to the SAHPRA regulations and Complimentary medicine registration with SAHPRA. The company was established in 2019.
We are a key player mostly in the health industry assisting organisations with getting Regulatory Compliance by completing applications for registrations and Licenses with SAHPRA for both Medical devices and Medicines CTD format Reviews and compilations.
What we offer:
- Implementation of ISO 13485: 2016 and ISO 9001: 2015
- Training for your staff on ISO 9001 Quality management system
- Regular reviews of your Quality system
- Compliance with statutory requirements
- SAHPRA License registration and product listing
- Complementary medicine registration – Dossier review and compilation (eSubmission)