Pre-clinical Drug Development Services

To provide management and implementation services for lead drug candidate selection, and completion of pre-clinical pharmacology and toxicology programs to support the conduct of clinical trials and product registration in most regulatory regions (including Australia, Europe and USA).

SeerPharma pre-clinical drug development services will generate and manage the appropriate pre-clinical toxicology/safety and pharmacology programs or studies to support clinical trials and ultimately drug marketing application.

We can assist with:

• Pre-clinical strategy recommendations
• Pre-clinical toxicology program/study design and implementation
• Contract Research Organisation (CRO) selection
• Project management
• Study protocol development and review
• Study monitoring
• Report review

Other Services

• Resolve regulatory toxicology issues and provide representation at Local and Overseas regulatory meetings
• Conduct gap analysis to evaluate dossiers for completeness prior to submission to regulatory authorities
• Review and audit pre-clinical toxicology protocols and studies
• Provide expert regulatory pre-clinical toxicology advice
• Provide independent toxicology data reviews for submission to regulatory authorities and Human Research Ethics Committees (HRECs)
• Complete nonclinical modules of regulatory literature based submissions

SeerPharma pre-clinical drug development services can also organise and manage lead drug optimisation and drug candidate selection programs. We can assist with preparation of strategy documents and programs for lead drug optimisation and lead drug candidate selection.
 

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