Our Quality Assurance Services
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Compliance to US and EU requirements (the “Bridge”)
Align your operations with both FDA and European expectations, with experts on both sides of the Atlantic.
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GxP Quality System Building
End-to-end QMS drafting, implementation (e.g. eQMS, training) and review.
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GxP Auditing
Vendor, QP and due diligence audits, internal gap analyses and mock inspections.
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GxP Training & Coaching
GxP training, auditor training, and leadership and quality-culture coaching.
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QA-Clinic™
Confidential, expert Q&A handled by Subject Matter Experts under NDA.
Learn more Validation (CQV, CSV)
Commissioning, qualification and validation (CQV) and computerized system validation (CSV).
We Work Across the Entire GxP Array
We have Quality experts in all the pharmaceutical Good Practices on both sides of the Atlantic:
- GMPGood Manufacturing Practices
- GCPGood Clinical Practices
- GVPGood Pharmacovigilance Practices
- GLPGood Laboratory Practices
- GDPGood Distribution Practices
- GTPGood Tissue Practices
- GPPGood Production Practices (medicinal cannabis)
- GACPGood Agricultural and Collection Practices (medicinal cannabis)
Talk to a Quality Assurance Specialist
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What Happens Next
1. We review your inquiry within 1 business day.
2. A specialist scopes your engagement.
3. You receive a tailored proposal.