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PEC Credential Presentation


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A short presentation of Pharmaceutical eConsulting

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PEC Credential Presentation

  1. 1. Pharmaceutical eConsulting A/S - guidance every step of the way...
  2. 2. About Pharmaceutical eConsulting? Pharmaceutical eConsulting A/S is one of the leading solutions providers in Denmark within the area of regulatory operation.
  3. 3. Our Core Competence eCTD: Submission Compilation eCTD and Regional Guidance Consultation GAP Analysis (System and Processes) System Implementation EDMS: Implementation Globalisation Upgrade GAP Analysis (System and Processes)
  4. 4. Submission Compilation Our main service is compiling electronic submissions using our 21 CFR Part 11 compliant eCTD tool. We are responsible for eCTD applications from the pharmaceutical company Nycomed. yco ed
  5. 5. eCTD Projects We are helping several Danish pharmaceutical companies with the implementation of their own eCTD tool. Processes, pitfalls, considerations and system validation are some of the aspects we look into. e oo to
  6. 6. EDMS Projects Implementing or upgrading an Electronic Document Management System can be a major project. We are helping several companies with best practices, validation, GAP analysis and project facilitation.
  7. 7. Outsourcing PEC can assist you on an ad hoc basis e.g. in i peak periods, or if you seek a service k i d k i provider within regulatory operations who can manage these functions. g By outsourcing tasks to PEC, you will benefit from the improved efficiency, lowered overhead and reduced payroll expenses expenses.
  8. 8. References All employees have 10+ years in the pharmaceutical industry, working with implementation, validation and maintenance p , of EDMS, eCTD, regulatory databases and quality Tracking systems. Our customers are now benefitting from our industry knowledge.