Executive Consulting

Discovery & Preclinical ADME

PK and ADME samples

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.

GMP & Quality

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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.

Individual & Organizational Excellence

My focus is on delivering services you need when you need them

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.

My management consulting services are:

  • Fully customized to address your specific problem.
  • Scaled to fit your resources.
  • Available for remote or on-site assistance.
  • Guaranteed - if we do not meet your objectives as stated, we will refund your fee.

Benefits to previous clients include:

  • Decreased cost and improved performance from new service, equipment, and material providers.
  • Post audit improvement of quality or performance from existing suppliers.
  • Time- and cost-efficient design, execution, and reporting of IND enabling preclinical ADME studies.
  • A concise and action-oriented strategic and tactical plan for a targeted employment pilot project, with specific recommendations for project and leader success.

Contact me to discuss your objectives, outcomes, and measures for success

Contact Katrina