Toxicology Services

The two principals of Druquest have more than 60 years of combined experience in all phases of preclinical development and safety testing of pharmaceutical, biophparmaceutical, food additive, neutraceutical and medical device prodcts as well as environmental chemicals.  They have access to associates who are experts in unique products and special problems in drug deveopment.  We can subcontract with or refer you to speciaists as the need arises.

We offer a wide variety of services:

• Review and evaluation of data packages prior to in-licensing agreement

• Evaluation of the GLP status of your laboratories, identifying deficiencies, providing training in GLP principles for yor staff, writing SOPs for your laboratory or providing sampe SOPs.

• Scientific review of your program to date and development of a regulatory strategy, providing estimates of the cost to reach an IND.

• Design of individual preclinical studies and preparation of protocols.

• Assistance in evaluating CROs, selecting a CRO, obtaining competitive bids, monitoring the work and reviwing final reports.

• Writing or assistance in writing a pre IND briefing book an IND, NDA or European expert report.

• Evaluation of unusual and unexpected findings in safety studies, designing of mechanistic studies to elucidate and evaluate significance of these findings and/or preparation of position papers, placing the findings in perspective.

• Defense of study results or registration applications at the FDA, EPA or European agencies, including preparation of review papers and interpretive reviews of test results.

We subcontract slide preparation to a reliable GLP laboratory for you.