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.


We focus on providing quality advice and building strong relationships with our clients through a highly iterative process.

Strategic Design Process and Advantages


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