Overview

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Optimal Pharm/Tox Consulting, LLC is focused on providing Toxicology, Pharmacology, Biomarker, ADME services to the Pharmaceutical/Biotechnology industries, venture capitalists, start-up companies, medical device companies, and contract research organizations. 

Possess a strong knowledge of preclinical drug development and FDA and ICH guidance documents including GLP regulations for preclinical studies.

We work in an effective, flexible, reliable, and timely manner and identify the appropriate CROs/laboratories for your unique situation. 

We ensure that the process moves swiftly and efficiently and oversee all study activities. Perform literature-based safety reviews and risk assessments.

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Optimal Pharm/Tox Consulting will create a Toxicology/Pharmacology/DMPK program to support the development of your compound as well as review your existing nonclinical data packages.

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Toxicology * Regulatory * Pre-IND/IND  

EoP2 Meetings * Discovery Toxicology     Biomarkers * Mechanism of Toxicology                  Investigative Toxicology * Due Diligence * ADME Pharmacology * Small Molecules * Antisense Oligonucleotides * Biologics * Gap Analysis

Impurities * ICH * GLP *Program Management