Pediatric Development

Selecting the right molecules for development - Quickly identify the best drug candidates. Knowing what it takes to develop a successful drug, we help clients select the best molecules for development. Our unique integration of scientific capabilities enables us to provide a complete assessment of molecule “developability”. Through this, we quickly identify the best drug candidates – the potential winners – mitigating risks for our clients and shortening the time to reach the clinic.

Accelerating molecules through to proof-of-concept - Simplify early development and accelerate to Proof-of Concept.Proof-of-concept (POC) is a key milestone in the development of a new drug candidate. We understand the transition to POC needs to be fast and cost-effective.With fully integrated capabilities from first-in-human testing to seamless drug product supply for patient trials, we simplify early development and accelerate molecules through to POC.

.Accelerating products through to commercial manufacture - Speed the journey from proof-of-concept to commercial launch. The journey from proof-of-concept to commercial launch can be complex. Speed is critical but it shouldn’t come at the expense of product quality. Creating patient-centric formulations and scaling up from pilot-scale to commercial manufacturing, we help clients turn promising molecules into successful drug products.

Our streamlined approach to developing drug substance has been shown to reduce manufacturing costs by 50% from preclinical to Phase I.  To best support our customer’s needs, we have made significant investments in technologies and equipment to meet the increasing demand for complex small-scale drug substance manufacture. With more than 40 years of experience in synthetic organic chemistry coupled with extensive expertise in flow chemistry, synthetic biology and biocatalysis, we can optimize manufacturing processes and save months of development time for our customers. 

- Process Research and Development- Solid State Services

- Capabilities include:
- Salt Selection:
- Polymorph Screening- Amorphous Dispersions- Crystallization Development
- Solid State Characterization:
- X-Ray powder diffraction (XRPD)
- Theral Analysis (DSC, TGA)
- Hygroscopy (DVS)Hot stage microscopy
- Particle size distribution and particle enumeration
- Surface Area
- Solution and Solid State NMRFT-IR
- Dissolution/disintegration

Quotient Sciences has almost 30 years of experience developing a breadth of pharmaceutical formulations across a range of indications. Our innovative approach to formulation development integrates drug product development with clinical evaluation, combined with our experience with over 1,000 molecules at all stages of drug development.

- Formulations design 
- Pre-formulation screening
- First-in-human
- Solubility enhancement 
- Modified release
- Analytical Services 
- Process optimization & scale-up 
- Gamma scintigraphy

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.
- Phase I & II clinical trial manufacturing 
- Real-time adaptive manufacturing 
- Global supply management 

Quotient Sciences is a global player in commercial drug product manufacture of small molecule products for niche therapies including oncology and orphan drugs. Our commercial manufacturing facility located in Philadelphia is designed to handle your high-potency compounds.
Our commercial batch size capabilities include: - Up to 500kg for solid oral dosage forms
- Up to 350L for liquid formats using an automated filling line. In addition to manufacturing products for NDA, ANDA, MAA and JNDA registration, the Quotient team can support 505(b)(2) and CBE-30 filings.

Process validation and registration batches: Whether you are preparing for NDA, MAA or Japanese NDA, Quotient has the expertise and regulatory approval to manufacture your validation and registration batches for the U.S., U.K., Europe and Japan.

- Phase III and commercial drug product supply
- High potency API handling 

When you are looking for a partner who is dedicated to Phase I trials and early clinical development, rely on Quotient Sciences for the experience and expertise to seamlessly deliver your studies with the highest quality service and speed. We accelerate your molecule from first-in-human to proof-of-concept, helping you make critical decisions earlier and faster. Whatever Phase I clinical pharmacology study you require, you can expect a fully integrated program from study design and startup to data reporting.- Phase I
- Study types
- Special populations
- Human ADME
- Regulatory affairs
- Data Sciences
- Modeling & simulation
- Gamma Scintigraphy 
- Integrating pharmacy compounding and GMP manufacturing 

Delivering rapid bioanalytical data in discovery – preclinical – clinical. Bioanalysis is a critical step in the drug development process.  At Quotient, we are experts in the development, validation, and application of bioanalytical assays.  
Our dedicated team of bioanalytical chemists are globally recognized and possess over 40+ years of experience in supporting all stages of drug development, from early preclinical through to First-in-Human, Phase I and onwards to Phase II- III studies.

- Bioanalytical assay development, validation and application - LC-MS/MS 
- ICP-MS/MS
- GC-MS/MS


High resolution mass spec: - LC-TRAP-MS & LC-TOF-MS


- Rapid turnaround time of preclinical and clinical samples
- Even quicker with ‘Priority Analysis’ (72 hr TAT)


- GLP & GCP accredited laboratories
- Global compliance (FDA, EMEA, MHRA) 
- Expertise in specialist areas
- Insulin analogues and polypeptide drugs by LC-MS/MS
- Elemental analysis by ICP-MS
- Volatile drugs and biomarkers by GC/MS
- Metabolite Identification

You need data rapidly to make crucial decisions during a study. Faster data means we can provide our customers with earlier interim data and interim PK reports for on-study dosing and formulation decisions.
We understand on-study changes to early phase study designs and dosing are frequent and so our study strategy for study database design and reporting is built around flexibility and rapid implementation. We use eSource data collection procedures in our clinical units and a joint eSource/eCRF database. Data are available in the study database within hours of collection, ready for remote sponsor access.

- Data Management and Database Programming Statistics and Statistical Programming
- Pharmacokinetics
- Medical writing
- Standardizing study data with CDISC
- Statistics, Pharmacokinetics and Scintigraphy

 

Our Drug Development Consultants work with you to design and implement successful drug development programs. With industry leading scientific expertise across a range of technical disciplines, we help customers across all stages of development, from candidate selection to commercial launch.

Our consultants have a proven track-record of cutting across industry silos to reduce the time and cost of development.  With hands-on development experience across hundreds of drug molecules and product types, we’ll help you avoid critical pitfalls, manage risks and maximise the potential for success.

Accelerate your timeline, with flexible, on-demand delivery. We’ll design and develop your packaging, labelling and distribution strategy for Phase I, Phase II and Phase III clinical studies, so you’ll no longer have to worry about the challenge of getting your drug product to multiple sites in time for clinical trials.

We have extensive experience developing and manufacturing drug products intended for all major routes of delivery including oral, inhaled, topical, rectal and parenteral, so you can develop and manufacture your drug products with Quotient, then seamlessly integrate into a bespoke clinical trial supply program.

With over 40 years of experience and 160 employees, Arcinova provides drug substance, drug product and bioanalysis services to over 200 pharma and biotech customers worldwide

Quotient Sciences has almost 30 years of experience developing a breadth of pharmaceutical formulations across a range of indications. Our innovative approach to formulation development integrates drug product development with clinical evaluation, combined with our experience with over 1,000 molecules at all stages of drug development. 

Miami, FL/June 22, 2020 - Quotient Sciences, a global pharmaceutical development, clinical and commercial manufacturing organization, announced today the completion of a $1 million dollar pharmacy and laboratory expansion at their Miami, FL clinical pharmacology facility. 


The expanded pharmacy capabilities offer customers a quick and cost-effective way to start clinical testing, without the need for extensive CMC investment or API consumption at this early stage of development.

When you are looking for a partner who is dedicated to Phase I trials and early development,rely on Quotient Sciences. 

We accelerate your molecule from first-in-human to proof-of-concept,helping you make critical decisions earlier. 
Whatever clinical pharmacology study you require, you can expect a fully integrated program from study design to data reporting.

Collaboration Expedites Human Clinical Trials for COVID-19 Drug Candidate. A collaboration to accelerate the development of a lead COVID-19 drug candidate into human clinical trials was announced today [April 28, 2020] by Quotient Sciences, a leading provider of innovative drug development and manufacturing solutions, and CytoAgents, Inc. a privately help biotechnology company focused on the development of pharmaceutical products for treatment of infectious diseases.

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.

ANA Therapeutics, a Silicon Valley-based biotech startup, and Quotient Sciences, a leading provider of innovative drug development and manufacturing solutions, today announced a partnership to support the manufacturing of ANA Therapeutics’ drug candidate, ANA001 (niclosamide capsules), which they are developing as a potential treatment for COVID-19.

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.

Pharmaceutical commercial manufacturing - Quotient Sciences is a global player in commercial drug product manufacture of small molecule products for niche therapies including oncology and orphan drugs. 
Our commercial manufacturing facility located in Philadelphia is designed to handle your high-potency compounds.

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.