Commercial Manufacturing
How do I scale up my product for commercial launch?
Thank you for getting in touch.
If you have not heard from us in the next 48 hours, do not hesitate to call us on
UK +44 (0)115 974 9000 / US +1-800-769-3518
Pharmaceutical commercial manufacturing
Our commercial batch size capabilities include:
- Up to 500kg for solid oral dosage forms
- Up to 350L for liquid formats using an automated filling line
In addition to manufacturing products for NDA, ANDA, MAA and JNDA registration, the Quotient team can support 505(b)(2) and CBE-30 filings.
Process validation and registration batches
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.
Phase III and commercial drug product supply
Quotient can support all aspects of your drug product supply for Phase III clinical studies and commercial supply.
- Manufacture of all oral drug product dosage forms in our FDA-, EU- and PDA- approved facilities
- Packaging including bottles, blisters, tubs or tubes
Dosage forms
Quotient has vast experience across an array of dosage forms that we manufacture for registration and commercial supply, including:
- Solid oral dosage forms
- Oral solutions and suspensions
Project management
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.
High-potency API handling
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.
When you need commercial manufacturing for a simple or complex drug product, Quotient is your answer.
Learn more
Access our resources
-
Info SheetGlobal Formulation Development and Manufacturing CapabilitiesWe provide full service support for small molecule non-sterile programs, from dosage formulation development through to GMP clinical trial manufacturing and commercial drug product supply.
-
WebinarUpcoming Webinar: Strategies for Achieving Regulatory Milestones FasterSave your spot for our next webinar featuring a customer case study from Ensysce Biosciences on April 19, 2023. Dr. Vanessa Zann, Senior Drug Development Consultant, will be joined by Lynn Kirkpatrick, CEO of Ensysce Biosciences for this special presentation.
-
WebinarUpcoming Webinar: Quotient Sciences and Charles River Collaboration WebinarJoin experts from Quotient Sciences & Charles River for a webinar taking place on 18 May, "Integrated Strategies for Accelerating from Discovery to IND and Beyond: Charles River & Quotient Sciences Collaboration."
-
WebinarBioanalytical Strategies for Insulin Analogues & Other Large Peptides Using LC-MSLearn how our physiochemical-based approach enables us to accelerate the development of bioanalytical assays for insulin analogues from Michael Blackburn, Head of Bioanalytical Method Development and Labs.