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35 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.
Implementation of QMS system for medical device distributors and manufacturers compliant with ISO 13485:2016
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.