Compilation of NCE and generic CTD dossiers for medicines in South Africa and English Speaking African countries

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Medical device applications

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Complementary medicine applications

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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

4. Compilation of the Professional Information and Patient Information Leaflet

 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

 

All you need to know:

 Pharmacovigilance

Marketing code

Company specific training

AND MORE   

Comply with Local South African requirements for:

Market Authorisation Holder / Applicant Holder for Allopathic medicine/ Complementary medicine

Medical device products