President

President

Overview of Services

• Over 20 years of experience in pharmaceuticals, biologics, vaccines, combination products and natural health products across numerous therapeutic areas
• Project management of regulatory submissions across programs and several countries globally
• Preparation of clinical sections of CTA, NDS, IND, NDA applications as per Health Canada and FDA guidelines
• Dossier compilation, publication (eCTD), communication with agency and overall management
• DIN, NPN, CTA, CTA-A, CTA-N applications for drugs/biologics/medical devices to Health Canada
• Product Monographs, Package Insert, SmPC review as per CCDS and guidelines and assessment of gaps.
• Regulatory interpretation of Health Canada guidelines and development of strategies
• Submission of CTA applications on behalf of Investigators/Researchers to Health Canada and FDA
• Development and writing of clinical protocols, ICFs, IB, monitoring plans, SOPs, CSRs, Modules 1 and 2, QOS
• Dossier review and gap analysis
• Preparation of IRB/EC submission globally for local and central IRBs/ECs, submission and management at sponsor and site-level

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