Translational Pharmaceutics® for First-in-Human Studies - Info Sheet

In 2026 we are continuing with the Day in the Life Of series, where we interview the people behind the medicines and find out what drives them, and how they go to where they are today. The series gives a personal insight into what it's like to work in the pharmaceutical industry and contribute to patients' health. 

With over 30 years’ experience, Quotient Sciences provides full service support for small molecule non-sterile programs, from dosage formulation development through to GMP clinical trial manufacturing and commercial drug product supply.

Quotient Sciences, a leading global drug development and manufacturing accelerator, and UK technology innovation centre, CPI, have signed a memorandum of understanding (MoU) to form a Joint Venture (JV) aimed at accelerating the development of RNA-based therapies.

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.

Quotient Sciences Featured as part of MMV Annual Report

Many drug substances are extremely bitter or have other aversive attributes,which can make developing palatable drug products extremely challenging.This is a common problem seen in medicines spanning all therapeutic areas,from antibiotics and painkillers to antihistamines and decongestants. The careful design and development of formulated oral drug products is key to ensuring patient acceptability and compliance for achieving the desired clinical outcomes.

Senior Director of Product Development, Robert Cornog, and Senior Director of Integrated Development, Brad Rowe, recently contributed to Contract Pharma's feature on HPAPI outsourcing, "Why HPAPI Outsourcing Is Surging", explaining the evolving demand, regulatory shifts, and analytical challenges shaping the HPAPI contract manufacturing market.

Are you developing a new dosage form for an existing drug? 

Do you need to explore a different route of administration?

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

After another successful year of bringing the pharmaceutical community together at CPHI Milan in October, hear direct from the exhibitors on why the event is so important for them and the industry as a whole. 

Quotient is a leading expert in the application of physiologically based pharmacokinetic (PBPK) modelling and simulation (M&S) science to drug development. 

Using GastroPlus™ we advise our clients on the potential in vivo performance of drugs and formulations to inform product and clinical development strategies. 


Whether working in a consultancy relationship or as part of an integrated program of work, our PBPK expertise is underpinned by our unique and extensive experience in pharmaceutics, biopharmaceutics, DMPK and clinical research.

Providing expertise to support pre-formulation development

Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.

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.

With more than 30 years’ experience, Quotient is a leader in the development, manufacture and assessment of inhalation products, helping clients to accelerate molecules from first-in-human through to proof-of-concept. 

Our integrated capabilities and vast knowledge encompasses pre-formulation sciences, formulation development, device evaluation, clinical trial manufacturing and the clinical assessment of a variety of inhaled formats for nasal and pulmonary delivery.

High Potency Drug Development & Manufacturing

Highly potent active pharmaceutical ingredients (HPAPIs) are becoming increasingly common in drug development pipelines, especially in the oncology sector, as researchers search for therapies with greater selectivity and pharmacological activity. However, HPAPIs present additional CMC challenges due to the containment requirements to protect both the operators and manufacturing facilities. Their production processes may also require greater precision and control due to the very small quantities of drug present in the final dosage form.

Overcoming poor drug solubility and bioavailability challenges

Drug solubility has a significant impact on bioavailability. 70% of new chemical entities (NCEs) suffer from low aqueous solubility that can result in failure during clinical testing due to poor bioavailability. Selecting an appropriate drug formulation is imperative to the success of the program.

Project Management at Quotient – A True Partnership
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.

John McDermott, Executive Director, Drug Development Solutions - Quotient Sciences discusses Translational Pharmaceutics at CPHI Worldwide, and how a recent Tufts study has proven the significant savings and financial benefits for drug developers who use Translational Pharmaceutics.

Dedicated to adaptive early phase clinical trials and drug development, Quotient Sciences can help accelerate your molecule from first-in-human (FIH) to proof of concept (POC). We are focused on delivering the insight you need to design and deliver your clinical pharmacology program with confidence. Our fully integrated approach ensures seamless execution and high-quality results—delivered safely and rapidly

Achieve your molecule’s next milestone with fit-forphase drug product formulations, backed by trusted data and the expertise you need to navigate the increasing complexity of small molecule and synthetic peptide therapeutics. Our adaptive approach assures scalable solutions for your molecule’s development—from preclinical through commercial drug product formulation, manufacturing, and supply.

Translational Pharmaceutics® is a disruptive approach to drug development that helps you forge your own path to success and optimize every step by redefining the complementary, interconnected relationship between drug product design, supply and clinical testing. The Quotient Sciences Translational Pharmaceutics® platform integrates activities and adapts solutions to help you reach key milestones as quickly and efficiently as possible. A

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. 

With decades of experience in developing palatable pediatric and patient-centric formulations, Quotient Sciences is actively engaged in the development of pediatric products on behalf of pharmaceutical and biotech customers.

Our innovative approach to formulation development is based on our proven track record in early clinical evaluation delivering phase-appropriate formulations across the product development pathway from preclinical to late-stage. With expertise in simple and complex dosage forms, our approach has been validated through our work with over 1,500 molecules at all stages of drug development.

At Quotient Sciences, we recognize that careful selection of appropriate delivery technologies is key to the design of successful MR formulations. We have extensive experience in using a wide variety of formulation technologies, having supported hundreds of modified-release formulations over the last three decades. Coupled with our agile and flexible approach to clinical and commercial manufacturing, this makes us the ideal partner to provide an end-to-end solution for the development of MR drug products.

Quotient Sciences specialize in guiding drug products through the critical transition from late-stage optimization and registration batch manufacturing through to full commercial readiness. Our approach is built on rigorous science, regulatory alignment, risk-based focus, and operational flexibility.

As the number of poorly soluble compounds continues to increase in the industry development pipeline, conventional formulation strategies may not be sufficient to achieve acceptable levels of solubility in the gastrointestinal tract and hence absorption into the systemic circulation. Scientists will need to utilize advanced formulation technologies to maximize oral bioavailability.