Technical Support Examples

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, qualification, management, on-site monitoring, and audits (locally in China, plus APAC)

GLP study audits covering procedures, protocols, raw data, draft and final reports
Serve as the primary point of contact for nonclinical project coordination, ensuring clear communication between sponsor and vendors
Oversight of project timelines, deliverables, resourcing, and budget adherence throughout the study lifecycle
Proactive identification and resolution of study risks and issues
Support for regulatory inspection readiness

Services