Services

CONSULTING

Comprehensive support for building Combination Product Quality Management Systems Hands-on GMP Consulting and quality and compliance services for the biopharmaceutical and medical device industries Training - Available as a standard certificate curriculum, or customized to your specific organization's needs Combination Products Regulatory Affairs Guidance Executive Advisory Guidance and Support Multigenerational planning/ roadmaps Culture Change Management Program Management Design & Process Excellence; Design Thinking Quality System Audits QMS Remediation Connections and communications with regulators