From assessing to staff augmentation We got you covered
Consultants consult, we resolve: By understanding your areas of opportunities, collaboration on alignment of risks and prioritization of improvement areas; we develop the action plan and engagement of the organization for complete resolution.
We focus on developing an integrated process approach for all elements of your Quality System, including providing IT solutions to meet the current and future needs of your organization. Learn more
We take a process approach; understanding risk management and that protecting the patient is the best way to protect your bottom line. Learn more
We specialize in Total Product Life-cycle system development: Concept, Development, Technical Transfer from R&D into Manufacturing, Production, Post-Market Support. Establishing a process approach for proper communications and hand-offs. Learn more
Over 200 Quality and Regulatory professional through training and provided mentoring oversight to over a dozen Vice President level professionals to enhance their quality, management and process effectiveness skills.
Optimizing performance..enhancing compliance
News & Upcoming Events
Three days after starting a new job, I met the CEO in the elevator and introduced myself. Without skipping a beat, he said he was familiar of who I was, stating that I was that highly paid “Quality Overhead”. I was brought in to help turn around the Quality area. About 2 months later, I Read more about Quality is not Overhead[…]
Struggle with explaining Regulatory Requirements to upper management? Regulated industries have two masters: the regulators and CEOs; so why not develop strategic tools to serve both? Let’s use a process approach to determine how well your current practices meet your organizational needs: Defining business practices that meet Regulatory requirements is key for delivering product, services Read more about Business Centric Solutions for meeting Regulatory Requirements[…]