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IND Package

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Over 800 Assays Available

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IND Package

Home / IND Package
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A well-conceived and executed IND package/CTA-enabling preclinical program will provide you with a detailed assessment of your drug candidate and a timely pathway to filing. Before a new drug candidate can be administered to humans, a series of preclinical studies should be conducted to characterize the compound. IND enabling studies are integral to the IND package and must be included in the submission. Key components of the data package include pharmacology, toxicology and safety pharmacology, and ADME sections of the submission.

Before we begin executing your program, you will receive a strategic review and advice on the design and execution of your preclinical development studies:

  • Your proposed preclinical plan including proof of concept pharmacology, ADME, and toxicology studies will be analyzed in depth.
  • Our Gap Analysis will identify deficiencies, potential roadblocks, and hurdles and identify solutions.
  • Timelines for your program, objectives, and crucial milestones will be defined.

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

  • ADME scientists and toxicologists with extensive industry and CRO experience allow for optimal planning and execution of ADME and pharmacology-toxicology studies.
  • Highly experienced clinical pharmacologists work hand-in-hand with the preclinical/nonclinical scientists to ensure a smooth transition from preclinical to FIH studies.
  • State-of-the-art ADME, toxicology, FIH, and bioanalytical facilities.
  • Rapid execution and timely completion of all preclinical studies required for IND/CTA 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 nonclinical study reports.
  • Extensive experience in the preparation of ADME and pharmacology-toxicology sections of IND/CTA submissions.
  • Extensive experience in the preparation of Investigator’s Brochure (IB) and clinical protocols to ensure timely initiation of FIH clinical studies.
  • An experienced program manager plus a project manager will be assigned to ensure rigorous program oversight and adhesion to timeline.

Links to Relevant Documents

  • Choosing the Right Imaging Method to Produce Tissue Distribution Data
  • Human AME (Mass Balance) Studies
  • Confidently Choose A CRO to Support Your IND Efforts
  • IND-enabling Preclinical Studies
  • DMPK Overview
  • Positron Emission Tomography (PET)
  • Radiolabeled ADME Studies

Time is of the essence in Drug Development.

Contact the QPS Business Development Team Today!

Your link to a rewarding career.

Join the QPS team and be part of our growing organization.

Submit Your Resume

About qps

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  • Mission, Vision, and Values
  • QPS History
  • Bioanalysis Milestones
  • Locations
  • Meet Our People
  • Blog
  • Careers
  • Privacy Policy

Preclinical Services

  • Assay Finder
  • DMPK
  • IND Package
  • Pharmacology
  • Toxicology
  • Assay Finder
  • DMPK
  • IND Package
  • Pharmacology
  • Toxicology

Clinical Services

  • Early Phase Clinical Trials
  • Leukopak Services
  • Global Medical Affairs
  • Global Regulatory Affairs
  • Therapeutic Areas
  • Early Phase Clinical Trials
  • Leukopak Services
  • Global Medical Affairs
  • Global Regulatory Affairs
  • Therapeutic Areas

Resources

  • Brochures
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  • Milestones
  • Scientific Posters
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Headquarters Location

Delaware Technology Park,
3 Innovation Way,
Newark, DE 19711

  • +1 512 350 2827
  • +1 302 369 5602
  • info@qps.com

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