DEVELOPING INNOVATIVE STRATEGIES
ACHIEVING GROWTH
REGULATORY AFFAIRS
Compilation of NCE and generic CTD dossiers for medicines in South Africa and English Speaking African countries
Medical device applications
Complementary medicine applications
Compilation of -
1. Amendments/ Variations for submission to the regulatory authorities
2. License applications for SAHPRA; DOH; SAPC
3. Site master files
4. Standard operating procedures for regulatory departments
5. Compilation of the Professional Information and Patient Information Leaflet
TRAINING
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Comprehensive training on the ZA CTD compilation
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Inspection readiness
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Duties of the responsible pharmacist & deputy responsible pharmacist
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Professional Information and Patient Information Leaflet training
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Requirements for specific SADC English speaking African countries
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South African amendments/ variation requirements
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Variations to marketing authorisations in the EU
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Medical devices: overview of regulatory authority requirements
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A day in the life of a regulatory affairs pharmacist or officer
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All you need to know:
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Pharmacovigilance
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Marketing code
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Company specific training
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AND MORE
MARKET AUTHORISATION HOLDER/ APPLICANT HOLDING
Comply with Local South African requirements for:
Market Authorisation Holder / Applicant Holder for Allopathic medicine/ Complementary medicine
Medical device products
Contact Us
24 Parrot Avenue, Extension 1
Lenasia, Johannesburg, South Africa, 1827
Salma Ismail
011 852 5252
082 33 66822
Salima Mahomed
011 852 5252
082 6036575
OFFICE HOURS:
Monday to Thursday: 08:00 - 16:00
Friday: 08:00 to 13:00