​Transparent Pricing for World-Class GxP Auditing and Consulting Services.
Comprehensive Packages Tailored to your Business
GMP Audit Package
$3,000 (1-Day Audit)
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Pre-audit consultation to define scope and objectives.
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On-site or virtual audit tailored to GMP requirements
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Detailed audit report with risk-categorized findings (critical, major, minor)
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1-hour follow-up consultation to discuss findings and next steps.
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Add-ons: Additional audit days ($2,500/day), CAPA support ($200/hour).
Vendor Audit Package (CMO/CDMO Oversight)
$6,500 per vendor
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Comprehensive vendor qualification assessment
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On-site or remote vendor audit (1 day).
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Detailed report focusing on compliance risks and improvement opportunities.
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CAPA development and implementation support.
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Add-ons: Multi-vendor audit discounts (e.g., 3 vendors for $18,000)
Training and Workshop Package
$2,000 - $4,000
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Customized training content tailored to client-specific needs.
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Half-day or full-day session (in-person or virtual).
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Training materials, including slides, handouts, and quizzes.
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Certificates of completion for all attendees and post-training Q&A session (up to 1 hour)
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Topics Offered: GMP Basics, Audit Readiness, Deviation Management, Vendor Qualification.
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Add-ons: Recorded training sessions for future use ($1,000/license).
FDA 483/Warning Letter Response Package
$10,000 - 20,000
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Comprehensive review of FDA findings and client documentation
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Development of a detailed response strategy with actionable plans.
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Drafting and reviewing the formal response for FDA submission.
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Support during FDA follow-up communications (up to 3 months).
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Add-ons: Extended post-response support ($5,000/month).
Continuous Improvement Package
$7,000/month (retainer)
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Monthly site visits or remote support (up to 2 days/month).
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Monitoring and analysis of quality metrics with trend reporting.
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Updates to key QMS documents and training materials.
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Proactive risk assessments with actionable improvement recommendations.
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Add-ons: Additional site visits ($3,000/day).