BOWMAN FDA REGULATORY CONSULTING GROUP - Key Persons

Job Titles:

• Partner / Sr. Project Management Consultant - Project Management and Systems Management

Adrienne has over 18 years of experience in healthcare, project management and IT systems. She has been instrumental in the preparation of numerous regulatory submissions both domestic and foreign. She has extensive experience in establishing systems for the conduct of clinical trials. She received her MBA from Thunderbird School of Global Management and Certificates from U.C. Berkley in Project Management and Computer Information Systems; Analysis, Design and Management. She is responsible for overseeing project management and IT activities related to submissions.

Job Titles:

• Founder, Principal, President & CEO E - SubmissionsSolutions.Com

Expert in technologies, practical techniques and processes for producing paper and electronic submissions for pharmaceutical, biotechnology and medical device industries.

Job Titles:

• CQA & CQM - Managing Partner / Principal Consultant

Cal has been a VP or Sr. VP of Regulatory, Quality, and Clinical for the last 30 years at small, medium and large pharmaceutical, medical device, biotech and CRO companies. He has extensive first -hand experience in preparing, filing and receiving approvals for INDs, IDEs, ANDAs, NDAs, BLAs, 510(k)s and PMAs,. He also has years of frontline experience working with FDA to address quality, clinical and regulatory compliance issues. He is a frequent speaker and trainer at industry organizations on pharmaceuticals, bio-tech and medical devices. Cal is responsible for: development of RA strategic Plans, Compliance Strategic Plans, Direct FDA Project interface/coordination, project problem solving, and overall quality of all regulatory and quality work.