About Us
Austin Bio Consulting is a US-based consultancy, headquartered near Washington, DC. We provide expert strategic and technical regulatory guidance to clients facing the complexities of advancing potential therapies from the bench to patients. With an in-depth understanding of the evolving regulatory landscape, we specialize in helping organizations navigate the multifaceted challenges that arise with the development of novel products.
Austin Bio Consulting is a specialized partner in pioneering the ethical development of life-changing therapies and forging pathways for products that address unmet medical needs.
Services
A US-based consulting firm providing strategic and technical regulatory expertise to help
you navigate the challenges of advancing new therapeutics
REGULATORY STRATEGY
Clinical Trial Applications & INDs
Health Authority Meetings
Market Authorisation Applications
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TECHNICAL EXPERTISE
Nonclinical & Translational Science
CMC (Module 3 & IMPD)
Good Manufacturing Practices
Medical Devices & Diagnostics
MEDICAL
WRITING
Standard Operating Procedures
Regulatory Designation Requests
Briefing Books
Applications
Annual Reports
DUE
DILIGENCE
Mergers & Acquisitions
Business Development
Partnerships
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Specialties and Product Types
Biosimilars
Cell Therapies
Small Molecules
Diagnostics
Biologics
Gene Therapies
Medical Devices
Combination Products
Contact Us
Global regulatory affairs experts
Located in:
Rockville, Maryland
UNITED STATES OF AMERICA
A minority-owned business enterprise and women-owned small business
