Quality Management Consulting provides clinical product development and regulatory compliance expertise to help pharmaceutical, biotechnology, and medical device companies build quality systems and compliance into their organizations.  We can assist in building efficient quality programs that can be optimized through the discovery, development, and commercialization stages.

Our consultants understand key regulatory concepts and are skilled in building FDA-compliant quality management systems.   Our services incorporate years of industry experience with a thorough understanding of regulations governing development, manufacturing, and testing of drugs, biologics, and medical devices.

§  Quality Policies

§  Standard Operating Procedures

§  Vendor Qualification and Audits

§  Training Programs (GMP/GCP/GLP/Technical)

§  Deviations and CAPA Systems

§  Change Management

§  Internal Audits

§  Inspection Readiness

We have helped small start-up companies and established pharmaceutical firms create, implement, and improve compliance programs and quality systems.