Annual Product Report

What is unique regarding KPA offering or service?

As part of your regulatory requirements, annual reports must be produced and submitted. KPA expert team will offer you an end-to-end coverage, that includes not only the report generation, but also data quality checks, fast and reliable production of high quality reports, and expert opinion regarding the results. Your work is handled by experienced statisticians who can advise you of the major findings, and advise you on actions to take, all with high availability and response time.

KPA’s main benefits are in the following three areas:

  • Quality
    • Input - quality checks and enquiries to ensure that the dataset to be analyzed is reliable
    • Output – Professional reports of high quality and accuracy
  • Service
    • Availability
    • Quick delivery of reports for a large volume
    • Flexibility to customer needs and special requests
  • Statistical expertize
    • Producing all reports based on a standardized template
    • Professional analyses and graphs to meet FDA, EU GMP or other regulatory guidelines
    • Expertise in generating insights based on results

What activities and responsibilities are parts of KPA Professional Services?

  • Professional services including preparation of annual reports for drug manufacturers
  • Tailoring of standard reports according to regulatory guidelines
  • Consulting in the event of non-standard data/results
  • Special/additional analyses for specific customer needs
  • Quality checks and enquiries regarding discrepancies/missing items in the data

What are the main deliverables/achievements?

  • Ability to cope with large volumes of production in a short time
  • High quality assurance for dataset input and report output
  • Flexibility to customer needs and special requests
  • Special/additional analyses for specific customer needs
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