Pharmaceutical eConsulting A/S is a leading regulatory solutions provider in Denmark that specializes in eCTD submission compilation, eCTD and EDMS implementation, and guidance on regulatory processes. They help pharmaceutical companies with tasks like implementing eCTD and EDMS systems, compiling electronic submissions, and providing outsourced regulatory functions and advisory services. All of their employees have over 10 years of experience working with electronic submission and document management systems in the pharmaceutical industry.
3. Our Core Competence
eCTD:
Submission Compilation
eCTD and Regional Guidance Consultation
GAP Analysis (System and Processes)
System Implementation
EDMS:
Implementation
Globalisation
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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.
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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.
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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.
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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.
