Who We Are
Our History
Founded in 1993 by former FDA officers, Biologics Consulting was established as a fully employee-owned (ESOP) company. Initially focused on vaccines, over the years, the company expanded to become a full-service, multidisciplinary regulatory affairs consultancy firm with services encompassing biologics, pharmaceuticals, medical devices, and combination products.
For over three decades since its founding, Biologics Consulting has assisted clients worldwide in addressing nonclinical, clinical, product development, and regulatory compliance challenges, helping them bring innovative, safe, and effective products to the U.S. market.
Our Mission
To improve public health by serving as the essential strategic partner for our clients, navigating complex global regulatory pathways to accelerate the development and delivery of life-saving and life-enhancing medicines and medical technologies to patients worldwide.
Our Values
- Collaboration & Inclusion
- Accountability & Ownership
- Integrity
- Innovation
- Driven by excellence
Our Difference
Regulatory Focus
Scientific & Technical Expertise
Regulatory Knowledge
Client Engagement
Our 5-step process to success
Scope and Diagnose
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Listen and understand client
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Commit to solution-oriented engagement
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Gap analysis
Model and Design
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Due diligence
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Model potential solutions
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Evaluate options for success
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Outline dependencies
Collaboration and alignment
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Prioritize options
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Propose path forward
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Determine approach
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Align on action plan
Execution and value realization
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Validate logic path
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Take action
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Deliver results
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Address challenges and seize opportunities
Evaluate and plan
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Leverage results and objectives for next step planning development
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Integrate best practices and key insights into long-term strategic solutions