World-leading expertise at the pace of industry

All of our projects are conducted in a framework that is timely, ensures intellectual property stays with the funder, and is guided by experts in commercial drug development. Below are some of the services we provide. We also develop capacity in areas of interest that are not listed on a project by project basis.

Drug Design, Target Discovery, and Validation

From computer aided design of drugs from the receptor up to high throughput screening of potential compounds, we can provide expertise that identifies and develops hits and lead compounds.

Lead Selection, Market Analysis, and Patent Strategy

With the complex and prohibitively expensive path from discovery to successful development it is critical to ensure that a drug candidate is as viable as possible. We provide analysis of the market, patent space, pharmacokinetic profile, therapeutic window, metabolic profile, efficacy, manufacturing process, and more to ensure a strong  business and scientific case for investors and regulators.

Regulatory support

We provide a wide range of expertise to ensure that work is done in a manner that will be compliant for regulatory bodies, from the development of a investigators’ brochure, to the guidance and completion of appropriate GLP/GMP/GCP studies, to liaising with the FDA, EMA, and Health Canada.

Medicinal Chemistry and Synthesis

We provide GMP compliant synthesis up to the quantities required for phase II clinical trials and support in developing commercial manufacturing for phase III and beyond.

Formulation

We provide a wide range of formulation solutions, from novel delivery systems, nano formulations, placebos, sterile dosage forms, semisolids and liquids, solid dosage forms, and more with a GMP compliant ISO 6 (class 1,000) and ISO 7 (class 10,000) cleanroom facility, extraction capabilities, and a Health Canada Site License.

Analytical Testing and Performance Characterization

We provide dissolution testing, disintegration testing, stability testing, accelerated stability analysis, analytical method development and more, including resources such as 600MHz NMR, LCMS, HPLC, etc.

In vivo and in vitro studies

We provide a wide range of pre-clinical research, including ADME, pharmacokinetics/toxicokinetics, pharmacodynamics/pharmacology, drug-drug interaction, metabolite identification, safety, hERG, and more.

Clinical Trial Design

We provide a robust methodology to ensure that clinical trials are well designed and executed. Some of our services include protocol development, PK analysis, biostatistics, study management, clinical monitoring, medical monitoring, and clinical pharmacology strategy development.

Population Pharmacokinetics (popPK)

We specialize in popPK, an innovative method in clinical pharmacology that evaluates a drug in target population with fewer samples than would normally be required in a standard study. Using mathematical models popPK provides information that identifies and supports dose adjustments, and labeling claims. Regulatory agency emphasis on popPK continues to grow and popPK models can better inform decision-making in all stages of the drug development process. We provide popPK in a multitude of areas, including allometric scaling, clinical trial simulation and adaptive design, exposure-response, in vitro/in vivo correlation, and more.

Pharmacometrics

We have leading expertise in pharmacometrics, a field that quantifies drug, disease, and clinical trial information for drug development. Focusing on concentration-effect, dose-effect, PKPD relationships, physiological based PK modelling (PBPK), development of disease models and quantitative relationships between biomarkers and clinical response this area of science continues to be of growing importance to regulatory agencies.

Pharmacovigilance, Pharmacoeconomics, and Market Access

We provide services and training in pharmacovigilance/pharmacoepidemiology, market access consulting, and health system strategy with expertise in a wide variety of areas including biosimilar regulation and reimbursement.

To speak to a member of the API team about our capacity to take on a specific project please contact admin@appliedpharma.ca.