Quality Assurance & Systems

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PCP can provide fractional and interim leadership  for small companies that don't have the need for full-time QA leadership.   This may include participating in leadership team, board and investor meetings, making batch release decisions, conducting QA investigations and representing the company when investigations are conducted by third parties, providing oversight for quality activities conducted by CMOs and CROs,  providing leadership during investigations and audits, etc.

PCP can provide talent to conduct annual product reviews, batch record review, investigations, CAPAs, manage change control, conduct training, perform audits, manage policies and procedures,   conduct mock inspections and  provide fractional or interim quality management.

We can create procedural frameworks and author supporting documents (policies, SOPs, etc.) which meet GxP requirements and align to your business needs.  Need a document management  or records management strategy?  We can help with that too!

Looking for a comprehensive review of your quality processes and systems?  We can refine your existing quality systems process or help you establish a quality system that meets the needs of your organization.