About Us

About Us

We are a comprehensive consortium of experienced clinicians, pharmaceutical scientists, regulatory strategists & business development experts that provide product & business development assistance & solutions for the pharmaceutical, biotech, medical product & related industries.

From project conception to product launch, we provide a focused approach to the pharmaceutical & clinical development of drugs, devices & biologics for regulatory submissions.


We have 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 Opportunities
We can assist you with the development, production, quality and registration of drugs, biologics and devices.