Quality and Compliance

Critical for the success of any product is Quality and Compliance. From highly regulated and compliance driven products in the Medical Device and Pharma industries to the simple molding of a cellphone cover, the quality of the product and its compliance with key requirements are milestones to assess in essential areas. These areas include yields, Complaints, Escapes, CAPA, Non-Conformances, and critical training, among others.

Our team has vast experience making bold recommendations and implementing the required changes to materially improve your quality indexes creating a competitive advantage for your products and ultimately positioning your business as the preferred market choice.

Achieving the highest product quality is one of the foundations of any business to excel in your industry. It can be one of the main drivers to transform a low morale organization into an exciting business. Our team has been helping customers achieve this objective by working on remediation projects, developing quality system processes, and executing quality assurance roles. The following are some examples of the areas we have successfully accessed and have created significant value to our customers:

   ◘ Management and execution of Corrective and Preventive Actions (CAPA)
   ◘ Lot Release Process
   ◘ Supplier Quality
   ◘ Risk Management Remediation
   ◘ Change Control ECR/ECO
   ◘ Incoming Inspection
   ◘ Quality Improvement Plans (QIP)
   ◘ Equipment Calibration
   ◘ DHF Remediation