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About Q1 Associates

Q1 Associates LLC: a global consulting company that assists clients to meet Business Development, QA, RA, EHS, Supply Chain regulatory agency compliance requirements, provides the following services: consulting, training, auditing, Person-In-Plant, Gap Analysis, Quality Agreements, Corrective Action and Preventive Action Plans, Root Cause Analysis, Inspection Readiness Preparation, Mock Regulatory Agency Inspections, SOPs, Validation, Batch Record Review, Qualified Person services, and Risk Assessments. Q1 Associates supports clients worldwide in the following industries: Pharmaceutical, Medical Devices, Biologics, OTC, Cosmetic, Nutritional, Automotive, Aerospace, Energy, Chemicals, Packaging, Storage, and Distribution. Q1 Associates supports the following functional areas: Quality, Compliance, Regulatory Affairs, Clinical Affairs, Operations, Manufacturing, CMC, Regulatory Affairs, Supply Chain Management, Distribution, Storage, GxP, GLP, GCP, GMP, GDP, CROs, CLOs, CMOs, ISO Standards, Validation, Technical Services, Risk Management, Operational Excellence, FDA, Health Canada, EMA, UK MHRA, Mexico Cofepris, Japan PMDA, Australia TGA, China NMPA, WHO, India CDSCO, Brazil ANVISA, Korea MFDS, EPA, OSHA, DOT. Q1 Associates has completed projects, product approvals/launches, audits, gap analyses, and remediation in 33 countries such as: USA, Mexico, Canada, UK, Ireland, Wales, Czech Republic, Austria, France, India, Brazil, Australia, Germany, Netherlands, Italy, Belgium, Indonesia, Japan, Taiwan, China, Portugal, Switzerland, Macau, and South Africa. Q1 Associates has implemented, audited, completed Gap Analyses, and provided remediation for the following ISO Standards: ISO 9001, ISO 13485, ISO 14971, ISO/IEC 17025, ISO 14001, OHSAS 18001, ISO/TS 16949, ISO 45001, ISO 15189, AS 9100, ISO Surveillance and Re-Assessment Audits, working with all Notified Bodies, ensuring compliance with national, international standards. Global Expert, Executive

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