From assessing to staff augmentation: We have you covered

Translating complex regulatory requirements into business centric solutions….
With over 35 plus years of global experience in Medical Devices, Pharmaceuticals, Biotech and Combination products, we understand your needs and resource challenges to provide sustainable solutions

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.

Our Customers

Optimizing performance..enhancing compliance

Feedback from customers, who trust in our services

Exceeding customers expectations, delivering sustaining solution

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Let us know how we can assist your organization align, achieve and sustain..

Questions, comments and feedback are always welcomed
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