CEO: Salma Ismail. With over 26 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
COMPILATION OF NCE AND GENERIC CTD DOSSIERS FOR MEDICINES IN SOUTH AFRICA AND ENGLISH SPEAKING AFRICAN COUNTRIES
COMPILATION OF LICENSE APPLICATIONS FOR MCC/SAHPRA; DOH; SAPC
MEDICAL DEVICE APPLICATIONS
COMPLEMENTARY MEDICINE APPLICATIONS
COMPILATION OF SITE MASTER FILES (SMF)
COMPILATION OF STANDARD OPERATING PROCEDURES FOR REGULATORY DEPARTMENTS
COMPILATION OF AMENDMENTS/ VARIATIONS FOR SUBMISSION TO THE REGULATORY AUTHORITIES
COMPILATION OF THE PROFESSIONAL INFORMATION AND PATIENT INFORMATION LEAFLET