Two Pharma Guys Consulting

Our Mission: Two Pharma Guys mission is to deliver exactly what was committed to on time while providing outstanding customer service, communication, and leadership throughout the process. About US: Quality Assurance Experts with 50+ years combined experience in Pharmaceutical Quality, Manufacturing, QC, ARD, Facilities, Validation, and Continuous Improvement. Over 25 inspections directly hosted (FDA, EMA, DEA, ANVISA, Health Canada, Russia, and Turkey. How Can We Help? Backlog of Deviations? Processes Too Complex? Regulatory Commitment Overload? Auditing or Supplier Quality Backlog? Product Complaint Program Setup? Need to get ready for an inspection? Services: Quality Assurance - Audits and Assessments, Inspection Readiness, and Validation Support (Computer System, Equipment, Method, and Process Validations) Data Integrity Compliance - ALCOA+ Principles, Data Governance, and Audit Trail Review Deviation Management - Writing, Review, and Management of Deviations, OOS, Complaints, and Atypical Investigations Remediation Services - Regulatory Responses, 21 CFR Part 11, 210, and 211, Risk Management, and Product Complaints Operational Efficiency - Change Management, Continuous Improvement, SOPs, and Quality Plan Manufacturing and QC - Review of executed batch production and testing records