Services

A US-based staffing and 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

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

Austin Bio is a specialized partner in pioneering the ethical development of life-changing therapies

Specialties and Product Types

Biosimilars

Cell Therapies

Small Molecules

Diagnostics

Biologics

Gene Therapies

Medical Devices

Combination Products

Austin Bio helps you forge pathways for products that address unmet medical needs

Manufacturing

Translational Science

Clinical
Development

Market
Registration

International Reach

Africa (Sub-Saharan)
Central and Southern Asia
Eastern Asia
Europe and UK

Latin America and the Caribbean
Middle East and Northern Africa
North America (US & Canada)
Oceania (Australia & New Zealand)