DI Regulatory Consultants was formed in 1992 with a sound background in the regulatory requirements of the South African regulatory authority.
Our mission and vision is to provide excellent regulatory consulting services to both local and international clients.
Continuous internal and external training in good regulatory affairs practices and international guidelines, cGMP, CGLP and cGCP with an integrative quality management system, ensures that our staff are always conversant with South African and global regulatory requirements and that the quality of our work is ensured.
Lorenz docuBridge is utilised as our eCTD manager software which is fully compliant with the South African Health Products Regulatory Authority (SAHPRA) eCTD specification.
Our staff component comprises of qualified pharmacists and a dentist with post graduate qualifications (M.Sc., Ph.D, BChD and MBA, respectively) as well as qualified regulatory affairs associates (B. Sc., MSc. and similar).
(B.Pharm; MSc)
Experience: Management, Business Development, Regulatory, Quality Assurance and GxP
(Ph.D.Pharm)
Experience: Project management, Regulatory, Production and Quality Assurance
(B.Pharm)
Experience: Regulatory (Clinical Specialist)
(B.Pharm; MSc)
Experience: Regulatory, Production and Audits