Curanto Pharma has been approved by SAHPRA in 2020 as an Applicant and Holder of the Registration Certificate (Marketing Authorisation Holder).

We have more than 25 year practical experience, first-hand knowledge and a clear understanding of regulatory requirements in South Africa. We ensure that all our clients’ products are and remain compliant with the South African legislation and policies.

Curanto Pharma provides the services of Responsible Pharmacist, Deputy Responsible Pharmacist and Pharmacovigilance Officer;
Provide an office and services, office equipment and infrastructure;
Compile and maintain a Quality System, which include a Site Master File, Validation Master Plan, Quality Manual, Standard Operating Procedures and Technical and Service Level Agreements with third-party service providers according to the SAHPRA GMP Guidelines.
Act as local SAHPRA liaison and Holder of the Certificate of Registration (HCR)/MA Holder on behalf of the product owner;
Follow-up on the progress of the submissions; and
Maintain life-cycle management of dossiers on DocuBridge software through its regulatory consultancy company PharmaReg