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27 years experience in the pharmaceutical drug and medical device development industry. Drug trial design, development of documents relating to clinical trials: Protocol, Investigator's brochures IMPDs, SOPs, Patient documents - information leaflets and consent documents etc..
Registration of medical devices, all related regulatory services, implementation of QMS including compiling Quality Manuals compliant with ISO 13485.
Provision of pre- and post-registration Pharmacovigilance services.
Registration of medicines - Regulatory Intelligence services both pre- and post registration.
Training of clinical trial site staff in GCP. Lecturer to post graduate students in Pharmacology at University of Witwatersrand Faculty of Health Sciences.