Regulatory Haven, LLC

Regulatory haven, llc email format

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Regulatory Haven provides consulting services for medical devices with a focus on the following areas: US Agent representation, quality management system implementation, auditing, 510k submissions, ISO 13485 certification, CE mark, FDA 483 and Warning Letter remediation, developing global regulatory strategies, FDA establishment registration, FDA communication, quality program implementation, maintenance, auditing, GLP / GMP / processing / manufacturing establishment, product and process validation.
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