GMP - Mock FDA, ISO & Vendor Audits & Remediation
US Headquarters - In-Country China, India & South America GMP/GLP/GCP Auditors for Suppliers, CMOs and 'For-Cause' Audits!
01-856-437-5880
New Company Start-up?
Issued an FDA 483 or Warning?
Need a Self Assessment?
Get a Quick Turn-Key GMP System Compliant to meet & Exceed FDA Requirements
Audit, Gap Analysis, SOP Templates & Training - Managed by CAPA Management FDA SMEs
Protect your Company!
Turn-Key GMP & QMS Readiness
Turn-key solutions to get your company up and running within a CGMP Controlled Environment, avoiding FDA violations or Warning Letters.
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Get your products to the market faster.
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Avoid Company Liability
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Envision Your Return On the Investment (ROI)
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Operate in a State of Control with Confidence!
FDA Subject Matter Experts
Seeking a quick resolution to your 483s or Warning Letters? Let us help, fast and discretely.
CAPA Manager 6 Month Plan
***6 Months – CAPA Manager – Project Manager for Site Remediation and Gap Analysis Support:
Provide SOPs, and QMS templates to satisfy FDA GMP Compliance:
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Audit – On-site 2-day GMP Audit (1 Draft / Final Report)
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25 – Quality Assurance SOPs (see CAPA Manager)
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2-day on-site GXP Training by GMP Boot Camps SMEs – 1st Month.
- Quality Assurance Manual or Manual updates
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10 – Computer Systems & 21 CFR Part 11 Compliance SOPs
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GANTT Management and Project Manager – 6-Months***
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Audit – 1-day on-site GMP Audit – 6th Month. (1 Draft / Final Report)
Training materials includes 10 sets (Additional Sets available):
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Binder Workbooks – 300+ slide workbook
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GMP Handbooks or Medical Device Master Guide - 900+ pages.
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Certificate for each Attendee
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Monthly GMP Training Webinar for new employees.
$26,000.00
Gantt Driven QMS Project Management
CAPA Manager 12 Month Plan
***12 Months – CAPA Manager – Project Manager for Site Remediation and Gap Analysis Support:
Provide SOPs, and QMS templates to satisfy FDA GMP Compliance:
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On-site 3-day GMP Audit (1 Draft / Final Report)
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2-day on-site GXP Training by GMP Boot Camps SMEs – 1st Month
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40 – Quality Assurance SOPs (see CAPA Manager)
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10 – Computer Systems & 21 CFR Part 11 Compliance SOPs
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1 – Quality Assurance Manual or Manual updates
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6 – Validation Procedures
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GANTT Management and Project Manager – 12-Months***
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Audit – 2-day on-site GMP Audit – 6th Month. (1 Draft / Final Report)
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Audit – 1-day on-site GMP Audit – 12th Month. (1 Draft / Final Report)
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2-day on-site GXP Training by GMP Boot Camps SMEs – 12th Month
Training materials includes 20 sets (Additional Sets available):
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Binder Workbooks – 300+ slide workbook
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GMP Handbooks or Medical Device Master Guide - 900+ pages.
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Certificate for each Attendee
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Monthly GMP Webinar Training for new employees.
$48,995.00
***CAPA Manager
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Includes remote weekly 4-hour CAPA Manager meeting,
Gap Analysis updates and Gantt PM reports.
Additional months can be purchased for $2,995/month over Project Scope. Span across 2 days.
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Includes 4 hours of customization per procedure to satisfy the customer’s requirements.
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Additional procedures will be provided for $995 each with 4 hours of customization.
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Additional hourly rate for SME document modifications will be billed at $295.00 per hour.
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Quality Management Systems are available for quote. Microsoft Excel spreadsheets are available for free upon contract. Call for details.
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50% retainer required upon commencement of project with 25% due on the 3rd month, and remainder on the 6th month.