If you are an Emerging Biopharma company looking to expedite the development of your novel drug or product, you may need help understanding the different expedited programs the FDA and other global regulatory agencies offer, their benefits, and how each one works.  

At Senita, we can help you choose the most adequate expedited program for your product. We will assess your product and help you with the designation process. Each designation has specific qualifying criteria, program features, and application requirements.