IND Package

A well-conceived and executed IND-enabling preclinical program will provide you with a detailed assessment of your drug candidate and the most cost-effective and timely pathway to filing an IND.

Why perform your IND-enabling preclinical studies at QPS?

Before we begin executing your IND-enabling preclinical program, you will receive strategic review and advice on the design and execution of your ADME and pharmacology-toxicology studies:

  • Your proposed non-clinical plan including proof of concept studies, pharmacology and ADME studies, and toxicology/safety program will be analyzed in depth.
  • Your proposed non-clinical plan will be reviewed to identify deficiencies and potential roadblocks and hurdles and whenever possible solutions identified.
  • Timelines for preclinical development of your overall and individual programs will be mapped out and preclinical development objectives and crucial milestones will be confirmed.

During execution of your IND-enabling program you will benefit from QPS's operational strengths, strong scientific/regulatory pre-IND/IND support, and drug development experience.

Operational Strengths
  • ADME scientists and toxicologists with extensive industry and CRO experience allow for optimal planning and execution of ADME and pharmacology-toxicology studies.
  • State-of-the-art ADME, toxicology and bio-analytical facilities.
  • Rapid execution and completion of all pre-clinical studies required for IND submission.
  • All studies will be carefully monitored and every phase of the studies critically assessed for scientific rigor and quality.
  • Fast turnaround on high-quality non-clinical study reports.
  • Extensive experience in the preparation of ADME and pharmacology-toxicology sections of IND submissions.
  • An experienced program manager will be assigned to ensure rigorous program oversight.
Scientific/Regulatory Pre-IND/IND Support
  • Review and gap analysis of available data and pre-clinical development plans.
  • Advice on the design and timing of ADME, safety pharmacology, and toxicology studies.
  • Provide expert advice on ADME and pharmacology toxicology issues associated with a broad range of therapeutic areas.
  • Rapid completion of the ADME and pharmacology-toxicology sections of the IND to enable client to file the IND in a timely manner.
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