Evaluate and provide guidance on all aspects of regulatory strategy for product development

Plan and coordinate regulatory strategy (incl. options and potential pathways)

Prepare, coordinate and represent clients with the FDA 

GLP study audits (procedures, protocols, reports and data) and facility audits

Remediation services for correcting an FDA Form 483 (or FDA warning letter) fault or deficiency

Safety assessments for biologics, small molecules, biosimilars and combination products

Risk assessment of drug targets

Early phase de-risking mitigation and problem solving by custom-made tox strategies (in silicon / in vitro / in vivo)

Preparation and evaluation of preclinical safety packages to support various clinical development programs according to current guidelines (FDA, ICH, EMA, CFDA)

Planning, monitoring and reviewing general toxicology studies in drug development (GLP and non-GLP)

Risk assessment and strategies for qualification of impurities in production and final formulations

Serve as a primary point of contact for project coordination

Adherence to project timelines, monitoring of project resources, tasks, and budget

Integration of multiple functional experts for application review and maintenance

Nonclinical pharmacology and toxicology support for drugs and biologics

Early-stage development planning assistance

Nonclinical program review and strategic support for FDA submissions

Review of study protocols and reports for scientific merit and regulatory compliance

Nonclinical CRO selection and oversight support