At Quotient Sciences, we are a leading provider of ADME studies, with the scientific expertise to design and deliver human ADME programs in preparation for New Drug Application (NDA), Marketing Authorization Application (MAA), and global regulatory filings.
Whether you're approaching the end of Phase II clinical development or planning for your regulatory submission, we help you simplify the delivery of your ADME study and maximize data output.
Quotient Sciences' Synthesis-to-Clinic® approach pulls all the necessary elements required for the completion of a human ADME program together into a single, integrated program of work.
We drive efficient development and manufacturing of 14C drug products tailored to the specific requirements of your ADME program—including intravenous (IV) products to generate IV pharmacokinetic and absolute bioavailability data, where appropriate.
Whether conducting human ADME for New Drug Applications (NDA) or running in parallel with Phase II Proof of Concept (POC) studies, our Synthesis-to-Clinic® integrated ADME studies are enabled by applying Translational Pharmaceutics®.
we design and deliver human ADME programs in preparation for NDA, MAA, and global regulatory filings.
whether you're approaching the end of Phase II or planning regulatory submission, we simplify your human ADME study.
We offer a streamlined approach to 14C human ADME studies. Synthesis-to-Clinic®, an integrated program of work.
Our drug product and clinical pharmacology capabilities combine into a flexible drug development and manufacturing program: Translational Pharmaceutics®.
Quotient Sciences Translational Pharmaceutics® platform helps you accelerate to and through first-in-human trials and optimize formulations coming out of Phase 1 studies, with the ability to release and dose in our clinics in under seven days, adapt to emerging clinical data in real time, and more.
Contact us to learn more about the benefits of integrated Phase 1 clinical studies and drug product services with Translational Pharmaceutics®.
Quotient Sciences is a global accelerator of drug development, with services spanning contract research, development, and manufacturing that make us more than just a traditional CRO or a CDMO.
Our CRDMO offering includes:
-Testimonial from a UK-based pharmaceutical company specializing medicines for children
-Testimonial from a former specialty pharmaceutical company
-Testimonial from a global pharmaceutical company developing therapies for people with endocrine diseases
"Our small biotech company worked with Quotient Sciences on developing a complex formulation and validating the different iterations of the formulation in PK clinical studies using the Translational Pharmaceutics® approach. The project was successful, and we were generally impressed by the skillsets, professionalism, and courtesy of Quotient Sciences' scientists and other subject experts. We have also chosen to work with Quotient Sciences on two subsequent projects."
"Due to the low density and poor flow characteristics of our drug substance, we experienced significant blend and content uniformity issues. By transferring our program to Quotient Sciences, the development team was able to quickly produce demo batches through multiple blending steps and roller compaction using the Gerteis Mini-Pactor. The increase in drug load from 25% to 40% was a significant improvement as we prepared for future Phase II/III trials and this ultimately benefits the patients by reducing the pill burden. We have successfully manufactured several GMP batches of tablets at various doses using a common blend. Quotient Sciences is an outstanding drug development partner with a no-nonsense approach, excellent communication, speed, and robust, easy-to-review documentation, from analytical methods to master batch records."
"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."
"There is an art to the development of taste-masked oral products for pediatric indications. Quotient Sciences’ expertise in improving the taste, smell, and texture of oral formulations makes them the ideal partner for our pediatric clinical programs."
From the next generation of emerging biotechs, to Fortune 100 pharmaceutical companies, we have worked with countless companies across the pharmaceutical industry over the last 30 years. Speak with one of our experts to learn more about our capabilities and how we can help you reach your program's milestones.
