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DEVELOPING INNOVATIVE STRATEGIES
ACHIEVING GROWTH
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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
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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