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​Transparent Pricing for World-Class GxP Auditing and Consulting Services.  

Basic Tier

$200/Hour

1-hour consultation

Review up to 10 pages​

Email summary

Standard Tier

$250/Hour

2-hour consultation

Review up to 20 pages

Audit preparation

Premium Tier

$300-$400/hour

Comprehensive support

No document review limits

Mock audit & training

Comprehensive Packages Tailored to your Business

GMP Audit Package

$3,000 (1-Day Audit)

  • 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).

Quality Management System (QMS) Setup Package

$12,000 - 22,000 (based on scope)

  • Gap analysis and QMS document development.

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  • Employee training for up to 10 participants.

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  • 3 months of implementation support.

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  • Add-ons: Extended training sessions ($300/hour).

Vendor Audit Package (CMO/CDMO Oversight)

$6,500 per vendor

  • 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

  • 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

  • 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)

  • 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).

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