Ideal For:
- Internal & supplier audits
- Regulatory & ISO readiness
- Gap assessments & remediation
- CAPA effectiveness checks
- Short-term resource support
What’s Included:
- Experienced FDA, EU & ISO consultants/auditors
- On-site or remote audits/assessments
- Reports delivered in your format or ours
- Clear, compliant, actionable recommendations
- CAPA monitoring, effectiveness checks & close-out support
- Follow-up support for findings
Standards & Regulations We Cover
- FDA: 21 CFR Parts 11, 210, 211, 820 and related requirements
- EU Regulations & Directives: 2017/245, 246, Annex 1 and associated regulations
- ISO Standards: ISO 9001, ISO 13485, ISO 14001, ISO 17025 and other applicable standards
Promotion Details
- $995 USD (€995) for a one-time audit or assessment
- 1-day service (scope mutually agreed upon in advance)
- Promotional price exclusive of travel & expenses
Ready to Strengthen Your Compliance?
Stay ahead of regulatory demands and benefit from the support of experienced compliance experts with this limited-time offer.