Working smarter means leveraging industry best practices along with Life Sciences expertise to achieve compliance and ensure patient safety.

We understand the challenges you face keeping up with the continuous change of landscape within the FDA regulated Life Sciences Industry.  We utilize a risk-based approach to Quality and Regulatory implementation and remediation, ultimately protecting both the end-user and the manufacturer’s bottom line.  Let our Life Sciences experts help you!

 


 

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Have a gap in your current Quality System? Looking to be more efficient?

Navigating the interconnected web of Quality System elements can be challenging.  Our expertise in Quality System areas such as:   CAPA, Complaint Handling, and Supplier Quality, will ensure optimal efficiencies and traceability between functional quality system elements to meet your compliance goals.

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Need to document the control of your production facilities and processes? Moving production equipment?

Our experts can manage and provide support for all functional validation areas and implement multi-functional validation programs. We work utilizing a risk-based approach from Validation Master Plans through execution.

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Dealing with FDA Observations or Warning Letters? Looking to avoid them?

Working within the global regulated environment of the Medical Device or Pharmaceutical Industry requires specialized resources and focused skill sets. Our experts can help with a variety of areas, including post-market regulatory functions and FDA inspection preparation and remediation.