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Pharmaceutical eConsulting A/S
               - guidance every step of the way...
About Pharmaceutical eConsulting?




Pharmaceutical eConsulting A/S is one of
the leading solutions providers in Denmark
within the area of regulatory operation.
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)
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
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
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.
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.
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.

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PEC Credential Presentation

  • 1. Pharmaceutical eConsulting A/S - guidance every step of the way...
  • 2. About Pharmaceutical eConsulting? Pharmaceutical eConsulting A/S is one of the leading solutions providers in Denmark within the area of regulatory operation.
  • 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. 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. 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. 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. 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. 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.