Efficacy in vitro is not the only critical parameter for a successful drug. Can your laboratory confidently measure your candidate(s) in common biological samples? Do you need expert services to understand metabolic liabilities, drug-drug interaction potential, and early toxicology endpoints? What are the regulatory requirements for IND-enabling ADME studies? Call me to understand the regulations, science and technology behind your discovery/preclinical ADME data package.
Moving your new medicine or device into GMP production is a key step in bringing your new therapy to market. Do your service providers meet the quality standards required for your application? Do you have the right methods to measure the stability, identity, and purity of your drug product and drug substance? Do you have the nonclinical data package you need for your device? Call me for an assessment of the steps needed to get you to your next stage gate in development.
As an executive and decision maker, you are frequently faced with business and personal challenges that exceed your experience. Unbiased third-party assessment and coaching will help you identify risk points, devise new strategies, and plan new tactics. Through my business experience and certification as a Manager of Quality/Organizational Excellence I have the tools and expertise to help you dramatically improve your personal and organizational performance.