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Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Iacopi, Jill, BA
Business Name Moonbay Technology
Certifications
Education

University of Washington

Business Address PO Box 1322
El Granada, CA 94018
USA
Contact information
Telephone:
Mobile Number:
Email address:
Website URL:
Specialties

Regulatory Affairs Services and Software

 

Experience

Regulatory Affairs and Submissions-IND, NDA/eCTD, CMC, clinical, non clinical, expedited safety reports and annual reports, support of regulatory strategy and due diligence

Clinical Research Support-GCPs, review of FDA form 1572, Investigator CV, financial disclosures, informed consent, investigator brochures, protocols, IRB approval letters, drug shipments, clinical study reports, serious adverse events (SAEs)

Quality Assurance-QC review of submission documents, FDA 483 and warning letter response, GMPs, quality systems development and training and SOP authoring and review.

Products-Pharmaceuticals (non-sterile liquids, parenteral, solid oral dosage form, anti-infective, combination products-drug and device), Biologics (monoclonal antibodies), Devices (lasers, class III)

Countries-United States, Canada, EU, India

Designed and developed Pipeline EDM™-computer control systems, computer system validation, 21 CFR Part 11 compliance, computer system development, electronic records & electronic signatures, technical support and maintenance

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