Quotient Sciences provides integrated pharmacy compounding, formulation, GMP manufacturing and clinical testing solutions to help clients achieve their proof-of-concept (POC) milestone quickly, saving them precious development time and money.  Begin your First-in-Human (FIH) Phase I testing with a fit-for-purpose, simple pharmacy preparation, and then seamlessly transition to a scalable, solid oral GMP drug product for Phase II trials, all within one organization.

Quotient has significant experience in 505(b)(2)
product development and can support you in efficiently turning your innovative ideas into successful products. Over the past several years, the FDA’s 505(b)(2) regulatory pathway has enabled the approval of a variety of differentiated dosage forms for existing molecules. There has been an increasing number of product approvals in the US using this approach and similarly, in the EU, the Hybrid Medicine Authorization process can provide new product opportunities for previously approved compounds.

Developing palatable dosage forms and masking bitter API

Palatability is influenced by multiple factors, including the chemical structure of the drug substance, the finished dosage form, and the excipients used in formulation. Many active pharmaceutical ingredients (APIs) have aversive attributes, such as a bitter taste, that if left unaddressed, creates challenges in patient compliance.

To achieve therapeutic outcomes across therapeutic areas such as antibiotics and pain management, regulatory agencies including the European Medicines Agency (EMA) recommend assessing taste attributes in early clinical development. This evaluation can be performed through adult taste panels or literature review, and findings should guide dosage form selection to optimize patient acceptability.

Find out more about how we incorporate taste-masking strategies and formulation expertise to help you overcome these challenges and deliver effective, patient-friendly medicines.

Quotient is an innovative drug development and manufacturing partner supporting clients from candidate selection to commercial launch. With expertise in end-to-end Project Management and integrated project teams, we make drug development easier for our customers and dramatically reduce the time and cost of getting new medicines to patients.

We understand the challenges of managing clinical trials at numerous sites, in multiple countries. Quotient Sciences 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.

We can support a wide range of studies for both drug product and drug substance including packaging stability studies. We can also support studies involving radiolabelled compounds and controlled substances. We can accommodate short duration studies lasting a matter of weeks, to long term studies of months/ years. At some of our facilities, we offer not only ‘storage only’ studies, where sampling and dispatch is taken care of by our dedicated stability team, but ‘storage and test’ in which we can store, pull and test on site. Report generation and issue is managed through our Quality Management System, and reports are made available for client review and approval.

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. 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.

Human ADME studies from Quotient Sciences.

As a leading provider of human ADME studies, we have the scientific expertise and operational know-how to design and deliver human ADME programs in preparation for NDA, MAA and global regulatory filings. 

Peptide drug products continue to gain popularity in the pharmaceutical industry due to their high selectivity, high potency, and good safety profile. However, formulating peptides can present many challenges for drug developers because of their unique physicochemical properties.

CRDMO services that enable modified-release dosage forms to get to market. Fast.

Quotient Sciences capabilities for modified-release span the entire development pathway, from candidate development through to commercialization, reducing development risks and simplifying the supply chain for our customers. By taking a unique, integrated approach that is tailored to each program, we provide optimal results for our customers in the most efficient and cost-effective manner, getting new medicines to patients faster.