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Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Halverson, Craig, MS
Business Name Biologics Consulting Group, Inc.
Certifications
Education

Master of Science, Experimental Pathology

University of Southern California, School of Medicine, Department of Pathology (Hematology & Oncology Laboratory)

Los Angeles, California

Bachelor of Science, Chemistry and Biology

California State University at Fullerton

Business Address 952 16th Avenue East
Seattle, WA 98112
Contact information
Telephone:
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Specialties

Craig Halverson is a senior Regulatory Affairs and Quality Assurance professional with extensive hands on strategic and management experience building and leading RA, QA, QC functions within commercial biopharmaceutical product development organizations operating both domestically and internationally.

Craig provides a full spectrum of Regulatory Affairs, Quality Assurance and interim management services to both virtual and fully integrated companies. He emphasizes product development support for global regulatory strategy development, meetings with regulatory authorities, and IND, CTA, Orphan, Fast Track, NDA, 505(b)(2) NDA, ANDA, BLA, and MAA submissions and submission project management, as well as paper and electronic submission publishing.

Experience

Craig Halverson has over 25 years of industry experience from the bench to the board room focusing on Regulatory Affairs, Quality Assurance, Quality Systems, and Quality Control. That experience includes developing regulatory strategies, building and leading regulatory submissions, compliance and operations groups, and instituting quality systems in the context of drug, biologics, and in vitro diagnostics firms, including start-ups, virtual companies, and multinationals.

He has a strong history of global regulatory authority interactions and biopharmaceutical and IVD product approvals in the EU and eastern Europe, as well as in the US, China and other Pacific Rim nations.

Product categories include monoclonal antibodies, plasma derivatives, recombinant proteins, gene therapeutics, therapeutic live cell vaccines, synthetic peptides, ancillary medical devices, and blood screening IVDs.

Therapeutic areas include oncology, cardiovascular disease, infectious disease, inflammation, immune deficiencies, hemophilia, and hemostasis.

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