Advance your drug development efforts faster
By delivering integrated nonclinical strategies, Premier Consulting gets you to the clinic faster and supports your continued clinical development. When you partner with us for your nonclinical program, you can reach critical development milestones on time and within budget.
Strategic assessments
Nonclinical development options, including IND-enabling nonclinical/toxicology studies
Pre-IND meetings:
- Overall strategy and key questions to ask the FDA at pre-investigational new drug application (pre-IND) meetings
- Design of IND-enabling nonclinical/toxicology packages and writing of pivotal study synopses
- First-in-human starting dose
Nonclinical study design and execution
- Nonclinical study design, contracting, monitoring, and reporting (GLP and non-GLP) to maximize scientific quality and regulatory acceptance
- Ability to ensure nonclinical studies meet regulatory requirements (of the FDA, the EMA, the OECD, GLP compliance, etc.) and support clinical development
- Overall development cost reduction
- Ability to act as an extension of your team
- Ongoing nonclinical/toxicology study troubleshooting and input on GLP compliance issues
Regulatory Submissions
- Write and review nonclinical eCTD sections
- First-in-human starting dose (IND and CTA) and overall benefit:risk assessment (NDA and BLA)
- Excipient and impurity/degradant qualification, including in silico and QSAR analyses
- Biocompatibility assessments for devices and combination products
Tailored nonclinical solutions to meet your needs
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.
Experience
Our team brings diverse scientific and product development expertise in areas including ADME/PK, bioanalysis, CMC, pharmacology, toxicology, and early clinical development. We collaborate with Premier Consulting’s Development Strategists to streamline and advance drug programs, while leveraging Premier Consulting’s Quality Management support capabilities to stay at the forefront of quality and compliance standards. The compounds and studies we support include:
