Advance your drug development efforts faster
Premier Consulting provides a full range of solutions to help sponsors build and deliver fully integrated nonclinical strategies that get drug development programs to the clinic faster. Partner with Premier Consulting for your preclinical program and reach critical early-stage milestones on time and within budget. Our solutions include:
Development planning
- Gap analysis of existing nonclinical information for regulatory submissions, including INDs, NDAs, and BLAs
- Strategic input on nonclinical packages, including in silico, QSAR, and literature-based approaches to minimize or waive nonclinical testing
- Review, input, and design of IND-enabling packages
Development execution
- Study design and protocol development
- Vendor qualification, selection, and ongoing management, plus laboratory auditing
- Drug product development: Excipient qualification; QSAR assessments for DNA reactive impurities; device biocompatibility assessments; and toxicological assessments for impurities, degradants, etc.
- Study monitoring, including on-site observations and review of raw data
- Study analysis and reporting, plus report review and finalization
- Nonclinical project management
- Clinical protocol development: Nonclinical and clinical program integration, determination of first-in-human dose, identification of potential adverse events
- Writing, review, and editing of nonclinical sections of regulatory documents, such as pre-IND and other regulatory meeting packages, clinical trial applications, and marketing applications
- Ad hoc nonclinical support for regulatory submission development
Tailored nonclinical solutions to meet your needs
Full-service solutions
Many sponsors choose to run their studies in Canada, which offers world-class nonclinical laboratories, leading principal investigators, and globally competitive pricing. Based in Montreal, Premier Partners can help you advance your program through nonclinical development and into early-stage clinical. Close proximity to these resources ensures high-touch study execution services at favorable cost.
View our infographic to learn more about the 200+ nonclinical programs Premier Consulting has supported.
Customized solutions
For sponsors with specialized needs or selection criteria, our experience working with nonclinical laboratories around the world allows Premier Consulting to identify the most suitable partner. Throughout the development process, our experts keep your program on track through a range of services including RFP management, auditing, vendor selection and management, and study oversight. Contact us to learn more about our customized options.