Nonclinical pharmacology, ADME and toxicology support for drugs and biologics, and other therapeutic agents

Study design, protocol development, data interpretation & reporting - ensuring compliance with regulatory requirements

Risk assessment of drug targets and early leads. Early phase de-risking mitigation and problem solving by custom-made tox strategies (in silicon / in vitro / in vivo)

GAP analysis

Due Diligence: review toxicology data from licensing or acquisition targets

Risk assessment and strategies for qualification of impurities and excipients in APIs and final drug products

Evaluate and provide guidance on all aspects of regulatory strategy for product development, aligning with global regulatory requirements

FDA and EMA/EU meeting requests (e.g. pre-IND); Prepare, coordinate and represent clients with the agencies

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

Risk mitigation plans

Special designations (Orphan Drug, Fast Track, Breakthrough Therapy)

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

CRO selection, management, on-site monitoring & audits (especially China and India). GLP study audits (procedures, protocols, reports and data)

Serve as a primary point of contact for project coordination. Adherence to project timelines, monitoring of project resources, tasks, and budget

Cross-functional team leadership: Integration of multiple functional experts for application review and maintenance

Quality Assurance - compliance with internal quality systems

Early-stage development planning assistance