Drug & Biotechnology Development, LLC
↗Clearwater, USA
Drug & Biotechnology Development, LLC (D&BD) is a boutique pharmaceutical and biotechnology consultancy and CRO consortium. The firm provides a comprehensive suite of services including pre-clinical and clinical development strategy, regulatory submission support (IND, NDA, BLA, 510K), and GxP compliance auditing.
The company operates as a consortium of experienced clinicians, pharmaceutical scientists, and regulatory strategists. Its leadership, particularly Dr. Robert Bell, has been instrumental in the development and recent FDA approval of innovative therapies, most notably the needle-free epinephrine nasal spray, neffy®, through their affiliation with ARS Pharmaceuticals.
CLASSIFICATION
SIZE & FINANCIALS
Employees:1-50
Revenue:$1M-$5M
Founded:2004
Ownership:private
Status:operating
FUNDING
Stage:Self-funded / Revenue-generating
PIPELINE
Stage:Commercial
Lead Drug Stage:Approved (neffy®)
Modalities:Small molecule, Biologics, Drug-Device Combinations, Biosimilars
Active Trials:3
Trial Phases:Phase 1: 1 | Phase 2: 1 | Phase 3: 1
FDA Approvals:1
EMA Approvals:1
CORPORATE STRUCTURE
Key Partnerships:ARS Pharmaceuticals (Strategic leadership and R&D), University of Florida College of Pharmacy (Academic/Research)
COMPETITION
Position:Niche Player
Competitors:Cardinal Health (Regulatory Sciences), Parexel, IQVIA, Halloran Consulting Group
LEADERSHIP
Key Executives:
Robert G. Bell, Ph.D. - President
Richard Lowenthal - Consortium Expert
Scientific Founders:Robert G. Bell
LINKS
Website:drugbiodev.com
LinkedIn:LinkedIn Profile
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