PAI Preparation and Remediation

For Life Science companies, the regulatory Pre-Approval Inspection (PAI) inspection determines whether facilities, manufacturing processes, and controls used to produce and package products adequately ensure patient safety and overall product quality.  It is the equivalent of a final exam for all Chemistry, Manufacturing, and Controls (CMC) matters related to your product commercialization program.

Similarly to preparations for an FDA or EMA site inspection, a successful PAI outcome depends on appropriate preparation and a team approach. Since the PAI is a crucial step in bringing a product to market, it is critical to construct the right, experienced team to handle all aspects of the inspection. Not having an appropriate strategy or team may delay market release, which leads to losses in revenue and recognition.  For a $400 million per year product, opportunity cost losses can be greater than $1 million per day for each day delayed!

Kymanox provides experts in each of the following fields, all of which are applicable during a PAI audit:

  1. Quality Assurance (QA)
  2. Manufacturing
  3. Validation
  4. Facilities and Utilities
  5. Quality Control (QC)

Following a PAI, if a US FDA Form 483 is issued due to deficiencies in your quality system or conditions that violate the Food, Drug, or Cosmetic Act, it is extremely important to provide a high quality response promptly and identify your course of action to correct the findings within the FDA’s specified timeframe. Kymanox can assist you in preparing an effective response to an FDA 483 and Warning Letter and provide you with direction to ensure your quality system and processes are in full compliance with the regulations.

Our extensive experience in PAI preparation and remediation allows us to assist your company in a way that fits your process, budget, and schedule. Kymanox can help you manage the full PAI preparation and remediation process or step in as needed to provide support.

Here is a quick run-down on our experience:

  • 15-for-15 successful PAIs in 15+ years
  • 360-degree coverage and orthogonal approach for subject matter expertise (i.e., 100% of CMC PAI disciplines)
  • First-in-class product experience for Pharma, Biotech, and Device
  • Kymanox team has combined experience supporting 100+ different PAIs
  • PAI clients include 100% virtual to Fortune 50 firms
  • Excellent relationship and track-record with FDA
  • Proven past performance includes entire PAI program oversight, mock audits, gap assessments, process validation remediation, and more