Our Mission
BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutics areas to help drug developers advance treatments for the disease communities with high unmet medical need. We have assembled a team of globally-recognized experts in the rare diseases and other under-served disease areas, including former FDA staff, and a variety of scientists who have many successful orphan drug designations and other expedited program submissions to their credit. We maintain a completely customer-centric, transparent process through the entirety of our projects.
Competitive Pricing
We use project-based pricing instead of hourly or cost-plus billing to ensure competitive pricing.
International Scope
We have more than 100 clients from all over the world, including Europe, Asia, and the United States.
Proven Track Record
Our team has written 350+ expedited drug submissions with success rate of 100% when clients follow our guidance.
Relationship-Focused
We focus on providing quality advice and building strong relationships with our clients through a highly iterative process.
Strategic Design Process and Advantages
- Skilled regulatory professionals specializing in the rare and unmet medical need disease space
- 100% success rate when clients follow BioPharma Global guidance for FDA expedited program submissions
- Understanding of disease prevalence and epidemiology
- First-hand experience with FDA OOPD's unwritten rules
- Ability to evaluate accelerated regulatory path options and clinical development landscape
BioPharma Global has extensive regulatory experience in disease areas with high unmet medical need. Our projects are made up of:
- Oncology
- Hematology
- Gastroenterology
- Allergy and Immunology
- Hepatology
- Genetics
- Neurology
- Nephrology
- Ophthalmology
- Metabolic
- Cardiology