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.
Access Our High Potency Fact Sheet
Quotient Sciences High Potency Handling Capabilities
Quotient offers complete end-to-end services for the development and manufacture of highly potent compounds (HPAPIs) from Preclinical through to Phase III/Commercial Manufacturing. When it comes to HPAPIs, we take an integrated approach to their handling and containment requirements which encompasses our facility design, engineering controls and operator safety.
Access our latest data sheet to learn about our highly potent handling and containment capabilities and how Quotient can help support your HPAPI program by clicking here.
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.
Accelerating formulation development to address poor drug solubility using Translational Pharmaceutics
This webinar examines how to accelerate formulation development in order to address poor drug solubility using Translational Pharmaceutics, showcasing examples of how Translational Pharmaceutics has been used across all phases of clinical development:
Drug Product Strategies to Accelerate from Candidate Selection to Proof-of-Concept
This webinar will summarise how a fully integrated development plan can bring together the needs of the drug product team and the clinical development team.
How can you conserve cash and still accelerate to your key early development milestones?
This webinar will explore some of the challenges faced by industry today and discuss how early drug development timelines can be accelerated, whilst at the same time conserving cash flow.