VPA Services - QMRC

Quality Management & Regulatory Compliance (QMRC) Services

No biopharmaceutical company can afford an expense such as non-compliance, consequences can be having a product withdrawn from the market or having a high-profile approval delayed. Setbacks associated with routine agency inspections, as well as more serious Warning Letters are costly and often result in approval delays, product recalls, harm to reputation, and adverse impact on shareholder value. VPA’s experts can help with:

Auditing: GMP, Quality Systems, Management Controls, FDA-type Mock PAIs and Inspections, Verification Audits and Effectiveness Checks, Gap Analyses

Regulatory Compliance: 483/Warning Letter responses and other correspondence, Consent Decree remediation activities, preparation for or attendance at Health Authority meetings

Training: General GMP topics, Health Authority interaction and preparing for inspections, 1:1 mock interviews, auditing techniques

Inspection Management Process and Planning: Review hosting process and site presentations, tour routes, front/back room management, document management, employee coaching

Technical Writing: Validation Protocols and Reports, SOPs, Annual Product Reviews, agency correspondence, audit responses, strategic plans, trend analysis reports, other technical reports.

Data Trend Analysis: Collection, review, analysis and summary reporting for Deviations, OOS, Change Controls, CAPA, Complaints, Product Returns

Project Management: Compliance remediation activities ; managing capital projects; managing subcontractor teams, Operation Quality Management

Quality Management & Regulatory Compliance (QMRC) Brochure