One Group Inc

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