Quality to Market

Project Management, Software Quality, and FDA-regulated validation services for pharmaceuticals, medical devices, biologics, and biotech organizations

   Providing order to complex challenges



Project Management services ranging from single projects to overseeing a portfolio of projects. Specialist in PMI and Prince2 methodologies

Quality System consulting providing full coverage of quality systems

Audits – internal quality system audits Internal quality system audits can be conducted on all or part of the company's quality system, and can document current compliance to company SOPs (Standard Operating Procedures), or the need for improvement.

Vendor Quality Audits

Audit/Inspection preparation
[pre-audit] Pre-Audits are conducted to assure management that the organization will successfully pass an upcoming audit or inspection, or will highlight areas in need of improvement prior to the inspection or audit. Utilizes the 2-hat approach, 1) Inspector's hat audit, followed by Quality Coach hat review.

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