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Regulatory & Compliance

  • Project Management, Scheduling and Controls

  • Worldwide Regulatory Filing Strategies/Filing Documentation Reviews

  • Quality Engineering Supplier audits and qualifications

  • Quality Technical Reviews & Complaints

  • Audit, Inspection and PAI readiness

  • Certified Quality Auditors

  • Inspection Readiness

  • Remediation Plans

  • Quality Risk Management, Training & Certifications

  • Risk Based Project Prioritization

  • Data Integrity

  • Regulatory Compliance and Quality Systems/Quality by Design

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Office: +1 (877)-213-7740

USA/Global Headquarters:

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Guidewell Innovation Center UCF Lake Nona Life Sciences

Second Floor - Office 229-A 6555 Sanger Road Orlando, FL 32827

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​Additional Offices:

Dorado, Puerto Rico

Barcelona, Spain

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