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Brief History

CEO: Salma Ismail.  With over 30 years experience & expertise in the Pharmaceutical Industry and in Regulatory Affairs and includes Legislation, Technical issues, Marketing Regulations, Training within the Pharmaceutical industry and covers New Chemical Entity, Generic and Biological submissions to regulatory authorities within the specific country.

Expertise in academia by lecturing on relevant Pharmaceutical Regulatory matters in Universities in South Africa.

In 2004, her entrepreneurial spirit motivated her to start up her own company - Twinz  Regulatory Affairs Pharmacist Consultants. This company has aided the social standing of the community at large with job creation with the current BBBEE level 1 status.

Twinz  Regulatory Affairs Pharmacist Consultants have been instrumental in servicing pharmaceutical companies with new regulatory submissions and amendments across the African continent with positive outcomes and assisted some of the world leading companies by providing Regulatory based training to their staff enabling South African Regulatory Affairs on a whole to reach international standard.

Twinz Regulatory Affairs Pharmacist Consultants Expertise

1

COMPILATION OF NCE AND GENERIC CTD DOSSIERS FOR MEDICINES IN SOUTH AFRICA AND ENGLISH SPEAKING AFRICAN COUNTRIES

5

COMPILATION OF LICENSE APPLICATIONS FOR MCC/SAHPRA; DOH; SAPC

2

MEDICAL DEVICE APPLICATIONS

3

COMPLEMENTARY MEDICINE APPLICATIONS

6

COMPILATION OF SITE MASTER FILES (SMF)

7

COMPILATION OF STANDARD OPERATING PROCEDURES FOR REGULATORY DEPARTMENTS

4

COMPILATION OF AMENDMENTS/ VARIATIONS FOR SUBMISSION TO THE REGULATORY AUTHORITIES

8

COMPILATION OF THE PROFESSIONAL INFORMATION AND PATIENT INFORMATION LEAFLET

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