About Us

Drug & Biotechnology Development, LLC (D&BD) is a comprehensive consortium of experienced clinicians, pharmaceutical scientists, regulatory strategists and business development experts that provide product and business development assistance and solutions for the pharmaceutical, biotech, medical product and related industries.  From project conception to product launch, D&BD provides a focused approach to the pharmaceutical and clinical development of drugs, devices and biologics for regulatory submissions.

D&BD has extensive experience with all phases of product development, including pre-clinical, clinical (Phase I-IV), CMC (analysis, formulations, process, production), outsourcing, CRO oversight and regulatory interactions, document preparation, review and filings.
Our clients range from the major multinational pharmaceutical companies to small start-up ventures and span all the continents of the globe. 

Over the past several years, D&BD has successfully assisted clients with:

• Regulatory Interactions
  • Pre-IND Meeting Submissions and Meetings
  • IND Submissions
  • End of Phase 2 Meetings
  • ANDA, NDA, BLA, PMA and 510K Submissions
• Compliance
  • International / Domestic GMP, GLP, GCP (GxP), CLIA, CAP, ICH, USP Audits
    • Manufacturing
      • Formulation / Process Development and Validation
      • API / Peptide / Protein Synthesis
      • Clinical Supplies / Packaging
      • Analytical Method Development and Validation
        • ICH, USP Method Validation
        • Part 11 Compliance
      • Stability
    • Bioanalytical
      • Method Development and Validation
    • Microbiology
      • CLIA, CAP, USP
    • Clinical Studies
      • Protocol Development and Review
      • Site Selection and Qualification
      • Investigator Contract Development
      • Integrated Summaries
      • GCP Audits
    • Quality
      • SOP Development
      • OOS and CAPA Programs
      • Laboratory / Instrument / Equipment / Facility Qualification
      • Audit and Training Programs
  • FDA 483 and Warning Letter Responses
  • Qualified Independent Expert Reports for Regulatory Authorities
• Product Development
  • Product Development Plans, IP and Patent Preparation
  • API Outsourcing
  • Project Management
  • Phase 1 Protocol Development
  • Vaccines
  • Peptide and Protein APIs and Formulations
  • Follow On Biologics
  • Natural Products
  • Transdermals
  • Oral Solids and Liquids
  • Sterile Products
  • Radionucleotides
  • Osteopathic Devices
  • In-vitro Diagnostic Reagents
• Due Diligence and Strategic Assessments for Mergers and Acquisitions Opportunites

D&BD can assist you with the development, production, quality and registration of drugs, biologics and devices.