How do I scale up my product for commercial launch?
Quotient is your answer.
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
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
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.
Global Formulation Development and Manufacturing Capabilities
We 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.
PBPK Modelling & Simulation
Quotient is a leading expert in the application of physiologically based pharmacokinetic (PBPK) modelling and simulation (M&S) science to drug development. Using GastroPlus™ we advise our clients on the potential in vivo performance of drugs and formulations to inform product and clinical development strategies.
Accelerating drug product development from early phase to scale up and commercialisation
This webinar covers a real-world case study with Druggability Technologies, a specialty pharmaceutical company, which utilized Quotient’s integrated approach to advance the development of DRGT-46, a novel, fast-acting formulation of celecoxib, using proprietary super-API compositions developed by DRGT.
High Potency Handling
With over 30 years of experience in small molecule drug development, Quotient Sciences possesses the expertise to overcome the challenges that arise with HPAPIs.