President | Regulatory Affairs & Quality Compliance Expert
Industry
Medical / Health Care / Pharmaceuticals
Website
About
Experienced in developing regulatory strategies for the health products industry relating to regulatory affairs, quality management, quality control (ISO, GMP, GCP, GLPs, CE Marking) & Environmental Health & Safety for various therapeutic areas. Specializing in establishing quality/compliance systems for start-up pharmaceutical (including sterile), biotechnology (blood products), medical device, NHP and cosmetic firms. Experienced in supporting legal counsel in preparing for litigation, compliance and privacy (PIPEDA). Provided expert opinions to law firms servicing health products industry. Expert in conducting and auditing validations including computer system (ERP).
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