Quality

Design, improve, assess, verify.  We know the ropes of cGMP compliance

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Documents

  • Quality Agreements
  • SOP Development & Review
  • Product Specifications
  • Certification
  • Due Diligence / Licensing
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Systems

  • Supplier Qualification
  • Change Control
  • Quality Audits
  • Investigations & CAPA
  • Supply Chain Integrity
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Compliance

  • GMP Readiness
  • Gap Assessments
  • PAI Preparation
  • 483 Responses
  • Warning Letters