Provide nonclinical drug development consulting and regulatory document preparation services.

At Quackenbush Consulting, we have more than 15 years' experience in preclinical / nonclinical research encompassing the drug development process in all phases from discovery through to post-marketing. Our focus on drug and vaccine development from both Sponsor and CRO perspectives makes certain that projects are done right and on time, providing you with peace-of-mind. Services include: ensuring GLP compliance (auditing, training), animal model development, test method development, oversight of...

At Quackenbush Consulting, we have more than 15 years' experience in preclinical / nonclinical research encompassing the drug development process in all phases from discovery through to post-marketing. Our focus on drug and vaccine development from both Sponsor and CRO perspectives makes certain that projects are done right and on time, providing you with peace-of-mind. Services include: ensuring GLP compliance (auditing, training), animal model development, test method development, oversight of animal studies including GLP-compliant toxicology studies, preparation of regulatory documentation (ND, NDA/MAA, responses to 483/Warning Letters), and program management/liaison between Sponsor and CRO.