Austin Bio Consulting
Austin Bio Consulting is a US-based staffing solution and consultancy headquartered near Washington, DC, specializing in providing strategic and technical regulatory guidance for the development of life-changing therapies. They help organizations navigate complex regulatory landscapes and forge pathways for products addressing unmet medical needs.
Industries
Nr. of Employees
small (1-50)
Austin Bio Consulting
Washington, District of Columbia, United States, North America
Services
Strategic planning and execution of regulatory pathways including clinical trial applications, INDs, health authority interactions, and market authorization planning.
Technical advisory services covering nonclinical and translational science, CMC documentation, GMP compliance, and medical device/diagnostics regulatory issues.
Authoring and compiling regulatory documents such as SOPs, regulatory designation requests, briefing books, applications, and annual reports.
Regulatory and technical due diligence for transactions, business development activities, and partnership evaluations.
Strategic planning and execution of regulatory pathways including clinical trial applications, INDs, health authority interactions, and market authorization planning.
Technical advisory services covering nonclinical and translational science, CMC documentation, GMP compliance, and medical device/diagnostics regulatory issues.
Authoring and compiling regulatory documents such as SOPs, regulatory designation requests, briefing books, applications, and annual reports.
Regulatory and technical due diligence for transactions, business development activities, and partnership evaluations.
Expertise Areas
- Regulatory strategy and submissions
- CMC and manufacturing compliance
- Nonclinical and translational science
- Clinical development and trial applications
Key Technologies
- CMC development and Module 3/IMPD preparation
- Good Manufacturing Practices (GMP)
- IND and clinical trial dossier preparation
- Market authorization dossier preparation