A well-conceived and executed IND package/CTA-enabling preclinical program will provide you with a detailed assessment of your drug candidate and the most cost-effective and 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. Investigational New Drug (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, ADME, and CMC 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, hurdles and identify solutions.
- Timelines for your program, objectives and crucial milestones will be defined.
During 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 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 of timeline.