Animal Health

Let Bioaccurate facilitate the timely success of your veterinary pharmaceutical programs through effective management to ensure studies are given the same priorities as human studies at the CRO, and that validations and sample analyses are planned proactively for success, and with audits to ensure that the data is defendable with the CVM.

Dr. Chris Tudan has nine years of experience working with veterinary pharmaceutical companies and coordinating with the CRO to ensure successful attrition and program successes in the GLP regulatory bioanalytical arena, including audits at the animal site. Having gotten his start with ELANCO and teaming with such globally known contractors as Debi Garvin, and having taught regulatory bioanalysis around the world, and for the SQA in the US, France and Switzerland, Chris comes prepared to assist your organization’s animal health agenda.

Examples of support has included:

Managing more than 14 different bioanalytical arms of veterinary pharmaceutical programs including tissue residue, formulations testing, generic testing and bioequivalence studies for a major pharmaceutical company.

Managing the outsourcing of methods validation and sample analysis as well as GLP study audits for multiple programs with a client specializing in preparing nutrients for animals intended for human consumption. Note that the analytical support was ICP-MS for which there was not Guidance, so Chris led the development of the current White Paper for the application*.

Managing the entire bioanalytical outsourcing for a virtual veterinary pharmaceutical company including methods developing right through to clinical trials and marketing (a topical animal therapeutic).

* Bioanalysis (2011) 3(15), 1695-1697 | Bioanalysis (2011) 3(15), 1699-1712