Premier Consulting

As a strategic product development and global regulatory consulting firm focused on emerging biotech and specialty pharma companies, Premier Consulting provides end-to-end services including regulatory strategy/planning/interactions with agencies like FDA/EMA/PMDA/etc., clinical design solutions, CMC/nonclinical/quality/commercialization support. They are known for deep expertise in 505(b)(2) pathways and rare/orphan drug development. They do not have their own clinical pipeline but help advance those of their clients. "Premier Consulting delivers end-to-end strategic insights from early-stage development through commercialization... Unparalleled clinical and nonclinical regulatory knowledge... Deep experience in 505(b)(2), rare disease..." "They assist clients from early-stage strategy... through regulatory approval and commercialization..." "We tailor development plans to meet the most rigorous global regulatory requirements..." No direct clinical results or pipeline since they are not themselves developing drugs.