© 2011 Bowman FDA Regulatory Consulting Group, LLC. All Rights Reserved
Cal Bowman, JD, RAC, ASQ: 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.
Adrienne Dionne, MBA, - 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.
Darla C., BS – Sr. Pharmaceutical and Medical Device Consultant
Darla has over 21 years experience in the pharmaceutical and medical device industry. She has managed, prepared and submitted numerous 510(k)s and PMAs in the Orthopedic Arena. She also has extensive experience directing compliance activities in both the oral pharmaceutical and medical device industries and is an expert in the design of Quality Systems. She has managed numerous FDA inspections and inspection responses. She has a BS degree in Industrial Engineering from the University of Texas at Arlington, TX. Darla is responsible for preparing medical device submissions and providing clients QA assistance. She is also responsible FDA compliance activities and conducting Due Diligence Assessments.
Michelle C., RPH, MS – Sr. RA Consultant – Pharmaceuticals
Michelle has over 19 years experience in the pharmaceutical industry and is a licensed pharmacist in NY and PA. She has held significant management positions in regulatory affairs and compliance. She has prepared and submitted numerous INDs, ANDAs and NDAs. She has extensive experience in preparing and submitting European filings. She also has special expertise in drug information and reporting, labeling, stability, and eCTD submissions. Michelle received her Pharmacy Degree from Purdue and a Master of Science in Quality Assurance and Regulatory Affairs from Temple University. She is responsible for developing strategic regulatory plans, conducting critical reviews of clinical sections and general administrative sections of regulatory submissions including required labeling. She is also responsible for QA of all pharmaceutical submissions as well as direct FDA interface on those submissions.
Tom B., Ph.D – Sr. Pharmaceutical RA Consultant- Organic Chemistry
Tom has over 16 years of pharmaceutical and bio-tech experience. 8 of those years were with FDA as a principal CMC reviewer. He has reviewed, prepared and submitted numerous CMC sections for NDAs in the Pharmaceutical industry. Tom received his PhD from Rensselaer Polytechnic Institute. Tom is responsible for providing technical advice on CMC sections of submissions.
James E., MD – Sr. Pharmaceutical, Medical Device and Biotech Medical Consultant
James specializes in Internal Medicine and has 19 years of medical practice experience as an Internist. He has participated in several clinical trials and is actively involved in establishing a clinical trial center. He received his Medical Degree from the University of Nevada. In 2011 he received the Compassionate Doctor Recognition Award and the Patients’ Choice Award. James provides medical consultation on pharmaceutical and medical device clinical trial design, and provides BRCG medical/clinical consultation on pharmaceutical, medical device and biotech submissions.
Charissa L., BS – RA Consultant - Pharmaceutical and Medical Devices
Charissa has over 14 years of experience in the health care industry and is a specialist in CMC for pharmaceuticals and medical devices. She has successfully prepared and submitted eCTD CMC sections for ANDAs and DMFs for both foreign and domestic pharmaceutical and API companies. She has medical device experience developing silicone products and using excimer lasers. She received her BA degree in Chemistry from UC Santa Barbara and is pursuing a MS in Chemistry with a focus on Regulatory Affairs from Lehigh University. Charissa is responsible for preparing CMC sections of pharmaceutical and medical device regulatory submissions.
Matthew N., PhD – Sr. RA CMC Consultant – Pharmaceutical and Biotech
Matthew has over 25 years of pharmaceutical and bio-tech industry experience, 16 at the Laboratory Director Level. Matthew has developed and implemented numerous new test methods in both the biochemistry and analytical chemistry fields. He is experienced in preparing and submitting all aspects of the CMC sections for INDs, ANDAs, NDAs and BLAs. Matthew received his PhD from the University of Chicago. Matthew is responsible for providing technical advice on analytical methods, stability, biochemistry and direct FDA interface for biochemistry related issues.
BRCG’s Core Consultants each have a minimum of 14 years experience in the Pharmaceutical, Medical Device and Bio-Tech. Industry. In total their experience exceeds 172 years. Their experience includes: all dosage forms, all levels of regulatory sophistication, and all levels of management from Team Leader to Sr. VP. BRCG’s consultants know how to work with companies of all sizes and best of all they know what works for companies at each stage of their growth.
BRCG consultants have successfully prepared submitted and received approval for over 40 INDs, 20 IDEs, 56 ANDAs, 38 510(k)s, 14 NDAs and BLAs, and 22 PMAs. They have successfully managed over 134 FDA inspections, FDA 483 responses and Warning Letters. They have conducted due diligence assessments domestically and internationally for numerous companies such as: Pfizer, Johnson & Johnson, Eisai, Bausch & Lomb, Novartis, and M8.
Expert in technologies, practical techniques and processes for producing paper and electronic submissions for pharmaceutical, biotechnology and medical device industries.