To date, we have had a 100% success rate on PAI Readiness projects for our clients.
Our team of experts is equipped to guide you through every step of any Inspection, especially Pre-Approval Inspections, due to the nature of their criticality.
Our industry experts will audit and evaluate all aspects of your organization that are vital to a filing and commercialization - Quality Management Systems (QMS), Development, Manufacturing, Laboratories, etc. Additionally, we can provide similar evaluations of your CROs, CMOs, and Testing Laboratories. It is important to note that any organization listed in the filing is subject to inspection and should prepare.
ProPharma will produce a report outlining observation criticality and recommendations to aid in remediation and optimization efforts for your firm.
Develop an Inspection Program or Optimize Existing Program
Develop an Inspection Program or Optimize Existing Program
Project Management is critical to the success of every project. No example is better than the importance of Project Management for PAI Readiness. Inspection Readiness has a multitude of simultaneous and associated activities. These activities include assessments and evaluations, remediation and optimization, logistics planning and execution, training, mock inspections, etc. And, of course, there is the ever present need to conduct "business as usual" concurrently. The everyday work does not stop while a firm is getting "Inspection Ready". The Project Manager will initiate, plan, and monitor all readiness activities with quality, budget, and timeline in mind .
Key focus areas for PAIs are far reaching. Among the most critical are:
Facing a pending filing and subsequent PAI can feel overwhelming, no matter if you are a young firm or an established company. You're balancing the excitement of bringing a new product to market with...
What is a Pre-Approval Inspection (PAI)? A pre-approval inspection (PAI) is performed to provide the Food and Drug Administration (FDA) assurances that a manufacturing site named in a drug...
When drug or device manufacturers apply for marketing approval of a new product, the FDA may conduct a pre-approval inspection (PAI). The PAI is performed to help the Agency assure that a...
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