PDF 357 kB
505(b)(2) Product Development at Quotient
Are you developing a new dosage form for an existing drug?
Do you need to explore a different route of administration?
Quotient has significant experience in 505(b)(2)product development and can support you in efficiently turning your innovative ideas into successful products.Over the past several years, the FDA’s 505(b)(2)regulatory pathway has enabled the approval of a variety of differentiated dosage forms for existing molecules