One Group Inc. was founded in 2015 to provide Validations, Quality, Regulatory and Compliance consulting services to the FDA regulated Pharmaceutical and Medical Device companies.

The company counts with more than 20 years of experience in the regulated industry and offers a variety of services including Project Management, Validations, Quality, Manufacturing support, and Packaging consulting.

Our Vision:
To deliver the highest quality and reliable service to reach our clients goals and exceeds their expectations.
 
Our Mission:
We strive for excellence and aim to exceed expectations. We work hard to achieve our goals and we encourage our resources to be ambitious. We are committed to growing our business through embracing technology, developing strong partnerships and by placing the emphasis on providing high levels of customer satisfaction.
 
We seek to excel in everything we do. We are committed to creating visible and sustained value for our clients. We are proud of our clients and what they think of us; we build long lasting relationships with them, responding to and anticipating their needs.

Our Services:

Validations / Qualifications
    Validation Master Plan
    Site Acceptance Tests
    Factory Acceptance Tests
    Manufacturing and Packaging Equipment and System Qualification
    Facilities, Utilities, Laboratory and Manufacturing Equipment  Qualification
    Test Methods Validation
    Process and Cleaning Validation
    Computer System Validation

Quality Assurance / Control
    Batch Records Quality Audits
    Change Control
    Statistical Analysis

Documentation
    Preventive Maintenance Procedures
    Calibration Procedures
    P&ID Drawings
    Commissioning / Decommissioning
    User Requirement / Design Specification
    Environmental Conditions Studies
    
Manufacturing/Packaging documentation
    Batch Records
    Standard Operating Procedures

Project Management
    Design, Lead, Close & Release

One Group Inc.

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One Group Inc.

Org chart

Teams

Offices

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