Management Systems

Comprehensive support for building combination product quality management systems.

 

GMP Consulting

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