DI Regulatory Consultants

About us

About DI Regulatory Consultants

DI Regulatory Consultants was formed in 1992 with a sound background in the regulatory requirements of the South African regulatory authority.

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 mission and vision is to provide excellent regulatory consulting services to both local and international clients.

Our staff component comprises of qualified pharmacists, pharmacists and a dentist with post graduate qualifications (M.Sc., Ph.D, BChd and MBA) as well as qualified regulatory affairs associates (B. Sc., MSc. and similar).

Members

Isabel Oliver

(B.Pharm; MSc)

Experience: 30 years in Management, Regulatory, Quality assurance and GMP

Charmaine van Eeden

(Ph.D.Pharm)

Experience: 16 years in Project management, Regulatory, Production and Quality Assurance

Rudi Oliver

(B.Pharm)

Experience: 14 years Regulatory (Clinical Specialist)

Emtia Perold

(B.Pharm; MSc)

Experience: 13 years Regulatory, Production and Audits

Personnel

Tanile de Bruyn

(B.Pharm)

Senior Regulatory Affairs Pharmacist

Experience: 10 years Regulatory (Clinical Specialist)

Zak Perold

(B.Pharm; PhD)

Senior Regulatory Affairs and Quality Assurance Pharmacist

Experience: 13 years Regulatory, Production, Quality control and Audits

Nina Pauw-Lategan

(B.Pharm)

Senior Regulatory Affairs Pharmacist

Experience: 10 years Regulatory, Medical Devices, ISO 13485

Elisma Badenhorst

(B.Pharm; MSc)

Senior Regulatory Affairs Pharmacist

Experience: 7 years Regulatory

Heleen Vlok

(BcHD)

Senior Clinical Specialist

Experience: 6 years regulatory (CAMS, Medical Devices and Clinical Specialist)

Joandie Nieuwoudt

(B.Pharm)

Senior Regulatory Affairs Pharmacist
Experience: 6 years Regulatory

Maides Jansen van Rensburg

(B.Pharm)

Regulatory Affairs Pharmacist

Experience: 5 years of Regulatory and Quality Assurance

Michelle Vivier

(B.Pharm)

Regulatory Affairs and QA Pharmacist
Experience: 1 year Regulatory experience

Marleen Breytenbach

(BScHons)

Senior Regulatory Affairs Scientist

Experience: 3 years Regulatory

Janine Olivier

(MSc)

Regulatory Affairs Scientist

Experience: 3 years Regulatory

Jan Kruis

(BSc)

Regulatory Affairs Scientist

Experience: 1,5 year Regulatory, Quality Assurance

Dihan Sutherland

(BSc)

Regulatory Affairs Scientist and eCTD expert
Experience: 3 years Regulatory

Charmaine Sullivan

(BSc Hons)

Certified Translator and Artwork Specialist
Experience: 13 years Regulatory and CAMS

Elize Trollip

DocuBridge and eCTD

Belinda van Eeden

Financial Controller

Gratia Botha

Administrative Coordinator

Shinead Brown

Administrative Coordinator

Lindsay Benjamin

Administrative Coordinator

Irvin Johnson

Administrative Assistant

Catherine Mobetwa

Administrative Assistant

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