1.Competitive Pricing: Because BIOPHARMA GLOBAL operates on low overhead, we utilize a project-based fixed-price model, eliminating cost overruns and thus significantly reducing risk for our clients. This means very competitive fees and lower costs.

2. Proven Track Record: Overall, our regulatory affairs team collectively has a successful track record of having written more than 100 orphan drug submissions with a first-time submission success rate of over 90-percent.

3. Extensive International Scope: We have more than 50 active clients from all over the world, including Europe, India, Asia, and the United States.

4. Our Team: Our team has a world-renowned reputation with assisting companies with the development of their Orphan and Regulatory strategy. No other firm can provide our level of expertise. Our team includes two recognized experts in the Orphan Drug space: Dr. Marlene Haffner and Dr. Sandi Heibel.

Dr. Haffner is a Board member and key adviser on many of our projects and was the Director of the Office of Orphan Products Development at the US FDA for over 20 years. She assisted with the development of over 300 products and is credited with the development of orphan regulatory programs globally. Dr. Heibel, Chief Science Officer of Biopharma Global, trained directly under Dr. Haffner. She has comprehensive knowledge of drug development research for rare diseases, regulatory strategy, submissions, scientific writing, and project management. In addition, our Senior Regulatory Officer, Ruth Hill, is a well-known and respected regulatory expert that has held multiple senior-level regulatory positions over a 20-year span. Ruth is best known for solving complex regulatory issues, strategy development, and for her expertise in CMC.