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In addition to manufacturing products for NDA, ANDA, MAA and JNDA registration, the Quotient team can support 505(b)(2) and CBE-30 filings.
Whether you are preparing for NDA, MAA or Japanese NDA, Quotient has the expertise and regulatory approval to manufacture your validation and registration batches for the U.S., U.K., Europe and Japan.
Quotient can support all aspects of your drug product supply for Phase III clinical studies and commercial supply.
Quotient has vast experience across an array of dosage forms that we manufacture for registration and commercial supply, including:
Quotient Project Management has over 30 years of experience in supporting drug programs that are in late stage development and commercial. Our project managers will ensure your commercial readiness by providing end-to-end support from concept and project scoping, to project delivery. And where projects transition across our sites, or intersect with other service providers, we’ll make the process seamless for you. For more information about Quotient Project Management, click here.
Using our experience across the industry pipeline, Quotient has responded to the challenges associated with the manufacturing of today’s high-potency drug products by ensuring our facilities are capable of handling compounds with a maximum performance-based level of exposure classification.