Compliance Gurus Inc Company And Services

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Company Information & Services
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    19-Oct-2014
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Transcript of Compliance Gurus Inc Company And Services

Page 1: Compliance Gurus Inc Company And Services

Company Information & Services

Page 2: Compliance Gurus Inc Company And Services

Company• Founded in 2003

• Supports the following industries:

• Biological, Cosmetic, Drug, Device, Dietary Supplements, Food

• Consulting Services

• Software Division

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Services• Internal Auditing

• SOPs, Work Instructions, & Policies

• Computer System Validation Documentation

• Manufacturing Documentation

• Laboratory Documentation

• Clinical Documentation

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Services• External Auditing

• Software & Hardware Vendors

• Raw Material & API Suppliers

• Drug Product Component Suppliers

• CROs & CMOs

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Services• Computer System Validation

• Manufacturing & Laboratory Systems

• Pre-Clinical & Clinical Systems

• Business Systems

• Warehouse Management Systems

• ERP & MRP Systems

• Network Qualification

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Services

• Equipment and Process Validation

• Existing Equipment

• New Equipment

• Plant Startups

• Commercial Process Validation

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Services

• Compliance Assessment & Report

• Pre-Clinical & Clinical

• Laboratory & Manufacturing

• Warehouse

• Compliance Assessment Report

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Services

• Quality System Implementation

• New

• Assess & Update Existing

• Reasonable Approach

• Functional

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Services

• Project Management

• Manage Projects

• Portfolio Management

• Portfolio Analysis

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Services

• Remedial Compliance Consulting

• EIRs

• 483s

• Warning Letters

• Untitled Letters

• Consent Decree

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Services

• Training

• Auditing

• GCP, GLP, & GMP

• Computer System Validation

• 21 CFR Part 11

• FDA Awareness

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Services

• Software Division

• Software Development

• Web Development

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Gregor Library

• FDA Documents

• 483s, EIRs, NDAs, Responses, Warning Letters and much more...

• http://gregorlibrary.com/

Page 14: Compliance Gurus Inc Company And Services

Thank You!

Michael J. GregorPresident, Compliance Gurus [email protected]

978.473.9265