Personalized Approach for Your Preclinical Studies
Creativity, Compliance, & Excellence
At iFyber, we don’t believe in a one-size-fits-all solution for your preclinical studies. Technology and product development in medical devices and pharmaceuticals require a wide and varied set of disciplines, methods, and people. iFyber’s scientists look closely at our customers’ needs and recommend the best course of action for the specific scenario rather than try to force them into a particular standard.
We have a GLP and GMP-compliant quality system and can validate methods and assays based on our customers’ needs. But when a project is still in the research phase, we will take the most direct and value-added approach to get to an answer—saving time and money on the way.
Sound Science. Superior Service.
Our direct approach to maintaining high standards and managing business risks during preclinical studies differentiates iFyber from other consultants and laboratories, and our sponsors and clients value that difference.
- Communication, paired with a critical examination of the required regulations, standards, and guidances, help our clients efficiently navigate the regulatory landscape with confidence.
- We believe conversations with regulatory agencies should happen early and often. iFyber works with the agency - not against them - when assisting with your filings and participating in your agency interactions.
- Our understanding of the quality requirements you operate within and the regulated development environment provides a framework for laboratory activities.
- iFyber has a GLP-compliant quality system and internal quality standards and processes that ensure that, when needed, your data will stand up to regulatory review.
- Over 50% of our technical team are multidisciplinary scientists who hold advanced degrees (Ph.D., M.S.) in several areas including microbiology, biomedical engineering, analytical chemistry, and synthetic chemistry.
Have questions about iFyber’s quality or regulatory approach to preclinical studies? Contact us today.
Explore Our Quality and Regulatory Consulting Services.