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Reglera, LLC

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Reglera LLC, a Leading Regulatory / Quality Consulting and Process Outsourcing Firm Specializing in Medical Device Announces New Outsourcing Capability

Contract Manufacturing Services Now Being Offered

Wheat Ridge, CO, May 16, 2012 --( Reglera LLC announces the addition of contract manufacturing services to its suite of outsourcing activities designed to accelerate Medical Device companies' efforts to cost-effectively bring their products to market. The contract manufacturing services will include the production of early prototypes, validation / clinical trial units and first commercial product. Reglera has the capability to manufacture both disposable medical products and electromechanical mechanical devices in its new manufacturing facility. The service will be conducted under Reglera's ISO 13485 certified quality system that will assure clients of high-quality product that meet all regulatory requirements.

With Reglera’s outsourcing programs, Reglera assumes responsibility for the execution of key functions such as document control, training, complaint handling, audits and now contract manufacturing. These services allow client companies to focus on strategic activities with the assurance that these key QMS functions are managed in an effective and compliant manner. Contract manufacturing is the latest of this group of outsourcing services requested by Reglera’s clients.

“This natural expansion of our service offering is being introduced to address a common need of Medical Device companies during their product development cycle. It is positioning Reglera in an even better place to deliver value to our existing and future clients as a 'one stop service provider' for the medical device industry worldwide,” said Clay Anselmo, Reglera CEO and President.

About Reglera
Based in Wheat Ridge, Colorado with offices in Ra’anana, Israel, Reglera provides regulatory and quality assurance consulting and outsourcing services to both the medical device and human cellular tissue industries worldwide. Whether developing a new product, improving an existing product, seeking assistance with the FDA, or simply trying to comply with the myriad of regulation and standards, Reglera's products and services accelerate success and profitability. With over 100 consultants and technical experts world-wide, Reglera is uniquely positioned to service clients from small start-ups to national and worldwide corporations.

For more information visit or contact Reglera LLC (US) at 303.832.8200 or Reglera (Israel) Ltd. at 972.9.748.4010.
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Reglera, LLC
John Keaveney

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