Pharmaceutical Consulting Solutions Llc

Pharmaceutical Consulting Solutions has extensive experience with FDA and offers solutions for internal, supplier, or third-party audits, audit readiness, Quality Management Systems (QMS), Manufacturing and Laboratory Investigations/CAPA, Internal Auditing, Analytical Validation, Equipment IOPQ, Computer Validation (GAMP 5) and Process Qualification. For medical device and combination products we offer support for Design Control (user requirements, design verification, design validation, design review, and trace matrix) and Risk Management (hazard analyses, FMEA's, FTA's, risk mitigation, risk management plan, and risk report) for development, FDA remediation, and lifecycle products. We can also develop strategy for mitigation of legacy products to meet current regulations.