Galenique Studio

This system is currently being upgraded. Upgraded version is expected to be release in late 2010 or early 2011.


PAIex is a virtual Pre-Approval Inspection (PAI) expert. It is capable of assessing current status of your company and guiding you from the very beginning to the last issues in preparation for your own pre-approval inspection. Utilization of PAIex enables you to prepare for the PAI, keep your management up to date with regard to your progress, and most importantly, give you very high probability of success in the PAI.

PAIex has a knowledge base that is comprised of the experience and expertise obtained during more than forty successful PAI inspections spanning an eight year period. These forty inspections represent more than twenty major pharmaceutical companies in the USA and Europe.


PAIex is composed of a number of key system components or modules, which are detailed below:

Core PAI Module:

This module contains the following components that are the most critical topics of a Pre-Approval Inspections:

  • Active Pharmaceutical Ingredient

  • Dosage Form Manufacture

  • Clinical Studies

  • Analytical Research

  • Contract Manufacturer and/or Packaging

  • Technology Transfer

  • Validation

  • Training

  • Procedures


  • Other Issues

These components have a detailed listing of several hundreds known FDA concerns. Each of these concerns has been given appropriate "weighting" by our domain experts as well as a criticality factor depending on their potential effect on the overall PAI outcome.

In addition the system is designed to permit continual updating. New progress can be entered into the "status" and immediately seen in an "Analysis" option thereby enabling the constant updating of the overall project. This is always available for updating management via a hard copy printout or electronic transmission. This report will provide the following items: % completed, feasibility for passing, number of kills, number of wounds, and number of no-kills.

PAIex is structured to designate responsibilities. The individual responsible for an activity can be shown as well as the departmental responsibilities. This enables management to constantly assess performance and status from the stand point of the people being held accountable

It should be noted that this expert system is clearly not just a check list but and interactive program containing a very large knowledge base.

This module also allows the user to challenge the system using fictitious requirements or actual, potential requirements.

Training module:

This module will assist the user in improving his/her knowledge in the requirements of the FDA. Guidance is also provided with regard to the advanced organization and preparation that is recommended to insure success.


A customized report is generated at the request of the user to present all or part of the following information:

  • The most problematic issues and the rationale for the concern over them

  • The potential for problematic issues to critically impact the overall outcome of the inspection

  • Which issues can be justifiably postponed without jeopardizing the final outcome

  • Which issues, even though they are not critical, could be completed and beneficially affect the outcome of the inspection

  • Instant overview of the departmental responsibilities as well as the individuals

  • Instant overview of the critical core activities

  • Projected outcome of the PAI

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