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Phoenix: Compliance Throughout Your Product's Lifecycle

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Staying in Compliance:
Medical Devices

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You don't need any regulatory surprises from your manufacturing process — especially those that result from lack of adherence to quality standards.

We can help you establish or review your processes to reduce the possibility of such surprises.

Our services include:

Audits

bullet point Conducting In-house and Vendor QSR Audits
bullet point Conducting Mock FDA QSR/CGMP, GCP & GLP Inspections
bullet point Conducting ISO Audits
bullet point Performing Due Diligence Audits

Training

bullet point Conducting in-house training for QSR and ISO

Part 11 Compliance

Computer Validation

QSR/CGMP Compliance Support

bullet point Assisting in Developing Design Controls and Validation Requirements
bullet point Assisting in Developing Quality System Requirements
bullet point Resolve QSR/CGMP Problems

Engineering Design

bullet point Designing New Systems and Facilities by Experienced Engineers

US FDA Agent for Foreign Companies


Please contact us for additional information or to get help now!

 

  APPROVAL | COMPLIANCE | REGULATORY PROBLEMS
WHO WE ARE | WHY CHOOSE US | SUCCESS STORIES | SITE MAP | CONTACT US
  Phoenix Regulatory Associates, Ltd.® | Phone: 703/406-0906
email: phoenix@phoenixrising.com