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Strategies for Accelerating the Development of Modified Release Oral Forms

How do I find a partner for clinical manufacturing?

Quotient is your answer.

Clinical Trial Manufacturing

Understanding that early phase clinical testing is a pivotal milestone in the development of your drug product, Quotient offers a clinical trial manufacturing, testing and certification service designed to meet your individual requirements. Our innovative method of building integrated GMP and GCP programs provides you with a streamlined, flexible approach to drug product supply that reflects your clinical study design and timeline. We understand the time and cost pressures you face during early phase evaluation and work with you to ensure a rapid, seamless path from development to clinical trial supply.

We understand your need to move rapidly through clinical development and have built the capability to efficiently scale up drug product manufacturing processes to meet the demands of global clinical and patient supply requirements.

Dosage forms

We offer you manufacturing and testing services for all major dosage forms including:

  • Solutions and suspensions
  • Drug in bottle, drug in capsule
  • Immediate, sustained and modified release tablets
  • Solubilized formulations including amorphous (spray-dried and HME) dispersions, micronized and lipidic formulations

Routes of delivery

We have extensive experience developing and manufacturing drug products intended for all major routes of delivery:

  • Oral (solid and liquid forms)
  • Inhaled (pulmonary, nasal)
  • Topical
  • Rectal
  • Parenteral

High-potency API handling

Take advantage of our state-of-the-art containment manufacturing for handling high-potency products which features isolator technology and engineered controls. Our containment classification is based on the Performance-Based-Level of Exposure Classification (PBLEC) allowing us to handle levels 1 through to 5 (or down to 0.1 µg/cubic meter) dependent upon the type of compound, dosage form and batch size. 

Phase I and Phase II clinical trial manufacturing

Quotient can support all aspects of your drug product supply to support your Phase I, II and Phase III clinical studies:

  • Manufacture of all major drug product dosage forms in our FDA and MHRA approved facilities
  • Packaging including bottles, blisters, tubs or tubes
  • Multi-language label design (including translation)
  • Post-study drug return and reconcilliation
  • Randomization and blinding
  • Schedule I - IV controlled substance handling
  • Shipment logistics and supply tracking
  • Storage and distribution capabilities (ambient, refrigerated and frozen)
  • Supply chain management to your clinical site

Real-time adaptive manufacturing

Our history and expertise of integrating manufacturing with clinical dosing enables us to manufacture, package and release products in a matter of days or weeks rather than months. Our approach maximizes flexibility around batch size and the timing of supply to your selected site, in response to emerging clinical data, or patient recruitment - all without affecting the availability of your drug product. Our approach can be used across all drug product types.

Project management

Our dedicated team of Project Managers is focused on delivering our customer’s clinical trial manufacturing projects on-time and on-budget. Quotient Project Management will provide end-to-end support from concept and project scoping, to project delivery, to making recommendations for late stage and commercialization. They will adapt along with your project to ensure your needs and the needs of your product are continuously met, that all risks are managed and mitigated and that all collaborators remain aligned with the objectives and end goal. And where projects transition across our sites, or intersect with other service providers, we’ll make the process is seamless for you. For more information about Quotient Project Management, click here.

Global supply management

Quotient Sciences understand the challenges of managing clinical trials at numerous sites, in multiple countries. We can ease the headache of global product supply logistics and accelerate your proof-of-concept timeline. We’ll develop and manufacture your drug product, and then seamlessly integrate into a flexible packaging, labelling & distribution strategy, tailored to your clinical trial. Find out more


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