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Pre-clinical Research, Toxicology & ADME

We provide full support to design and execute pre-clinical programs from as early as the discovery stage through pre-FIH, early and late-stage development.

Operationally we provide CRO selection, study design, placement and oversight/monitoring, data review, and reporting. Some examples of the pre-clinical support we offer are:

In vivo and in vitro pre-clinical studies to assess pharmacologic activity, pharmacokinetic/pharmacodynamic (PK/PD) relationships and support candidate molecule selection for development

In vivo and in vitro pre-clinical PK and ADME

Investigative and GLP-regulated toxicology studies (general toxicology, reproductive, developmental and juvenile toxicology, genetic toxicology and carcinogenicity studies) to support first-in-humans (FIH) IND package, later stage clinical development and global registration needs

Prepare special protocol assessment documents and carcinogenicity assessment committee packages.

Pre-clinical safety support for formulation development, drug substance impurity and degradant qualification, CMC specification support, leachables/extractables and container closure system considerations including drug/device combination needs

Assemble and manage pathology expert working groups and peer review panels for issue evaluation and resolution concerning end organ toxicity

Review of existing data packages, identify gaps/issues and develop strategies to address

Pre-clinical program design to support all stages of development through registration and life-cycle management including drug repurposixng and/or reformulation efforts

Preparation of regulatory submission documents, responses to health authority questions, and contributions to Investigator Brochures

Prepare for, attend and/or represent client in all face-to-face meetings with Health Authorities

Support for Advisory Committee meetings

Represent client’s company to investors/venture capital

Support client company with due diligence review of data packages for asset in-licensing or partnership
 

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