Quackenbush Consulting

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 pha...

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 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.