Human ADME Services at Quotient Sciences

How can I simplify the delivery of my human ADME study?

As a leading provider of human ADME 14C radiolabeled studies, we have the scientific expertise and operational know-how to design and deliver human ADME programs.

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We are a leading provider of human ADME 14C radiolabeled studies

Leveraging the services of Quotient Sciences helps simplify the delivery of your human ADME studies.

Operational know-how

Operational know-how

We design and deliver human ADME programs in preparation for NDA, MAA, and global regulatory filings.
Simplifying study delivery

Simplifying study delivery

Whether you're approaching the end of Phase II or planning regulatory submission, we simplify your human ADME study.
Synthesis-to-Clinic®

Synthesis-to-Clinic®

We offer a streamlined approach to 14C human ADME studies. Synthesis-to-Clinic®, an integrated program of work.

Leverage the expertise of Quotient Sciences, to benefit your business

Streamlined programs

Facilitated by Synthesis-to-Clinic®, we pull all the necessary elements required for the completion of a human ADME program together into a single, integrated program of work.

NDA, MAA & regulatory support

We have the expertise to design and deliver human ADME programs in preparation for New Drug Application (NDA), Marketing Authorization Application (MAA), and global regulatory filings.

Efficiently meeting milestones

We drive the efficient development and manufacturing of 14C drug products tailored to the specific requirements of your ADME program and milestones. That includes intravenous (IV) products to generate IV pharmacokinetic and absolute bioavailability data, where appropriate. From radiosynthesis through to clinical reporting, we deliver all of these components on your behalf under the guidance of a single project manager.

Achieve your drug program’s goals with one, integrated partner

Translational Pharmaceutics®

Integrated development platform that is proven to reduce timelines by >12 months.
Clinical Manufacturing

Clinical trial supplies for oral, injectable and inhaled dosage forms.
Clinical Pharmacology

Phase I healthy volunteer studies & 14C Human ADME.
Commercial Manufacturing

Tech transfer, Process Scale-Up & Optimization, Lifecycle Management.
Drug Substance

PR&D, Custom Synthesis and drug substance characterization.
Formulation Development

Simple & complex dosage forms: PIB, PIC, Tablets, Poorly Soluble, Modified-Release, Pediatrics.
Bioanalysis

Rapid bioanalytical data in discovery, pre-clinical & clinical.
Data Sciences

Rapid access to clinical data & results to accelerate drug development.
Consulting

Holistic scientific advice at each stage of drug development.

Customer success

Customer Testiomonials at Quotient Sciences

“The combination of GMP manufacturing and clinical testing within one organization was, as far as we are aware, entirely unique... The understanding we have gained through working with Quotient Sciences in terms of both the formulation development and the manufacturing will be invaluable.”

Dr David Hava, Chief Scientific Officer at Pulmatrix

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“The company’s ability to integrate manufacturing and dosing really accelerated the conduct of the study and was one of the main reasons that Corcept Therapeutics selected Quotient Sciences to undertake the study.”

Hazel Hunt, Chief Scientific Officer at Corcept Therapeutics

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“Quotient Sciences’ real-time manufacturing capabilities were a key factor in determining the speed at which this study could be concluded, offering the rare combination or GMP manufacturing and clinical administration on the same site, even for complex formulations and dosage forms. This allowed us to progress much faster.”

Dr Phil Collis, Vice President of Development at BioCryst Pharmaceuticals

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“My first response was this is too good to be true, they can’t do that. We’ve been looking for this type of solution for years – it can’t be done. However, we made a site visit and, within three days, accepted the proposal... We had clinical data within weeks... reducing the overall timeline by half, if not more.”

Deborah Gouveia, Vice President, Program & Alliance Management at Stealth BioTherapeutics

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“Quotient Sciences is an honest and straight-forward company with a very progressive attitude... What makes them unique is the way in which the pharmaceutical products are made on site and transferred, without leaving the building, to the clinical unit and a good, large and reliable pool of healthy volunteers.”

Gillian C. Ivers-Read, Former Executive VP & Chief Regulatory Officer of Clovis Oncology

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Who are Quotient Sciences?

More than a CDMO:CRO.

Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, molecules need to become cures, fast. Because humanity needs solutions, fast.

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