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Pharmaceutical eConsulting

21 Buckland Avenue
ZIP Code
United Kingdom

Company Profile:
Pharmaceutical eConsulting (PEC) consultancy for Life Sciences companies on eCTD and EDMS:
PEC are based in Denmark and United Kingdom, with the main service in compiling electronic submissions, to Life Science companies assisting with their regulatory publishing of eCTD, NeES and Paper submissions for Europe, USA, Health Canada and Rest of World. PEC has extensive experience with eCTD, and eCTD lifecycle management in both Europe, USA and Rest of World. We have assisted companies with implementing or upgrading an Electronic Document Management System providing companies with best practices, validation, GAP analysis and project facilitation.
Submission Compilation
eCTD and Regional Guidance Consultation
GAP Analysis (System and Processes)
System Implementation and Validation
Implementation and Validation
GAP Analysis (System and Processes)


eCTD submission service

What we offer:
PEC offer Outsource Submission Service as either an ad-hoc, extension to the existing regulatory operations teams, or a standalone outsource team. Any one or more of the following services can chosen at the time of requirement:
– Scanning Services
– Rendering MS-Word documents to PDF
– MS-Word Document Formatting
– PDF Publishing (Bookmarking and Hyperlinking)
– Submission Compilation and Life Cycle Management
– Paper Submission Services
– eCTD and Regional Regulatory Guidance Consultation
– GAP Analysis (System and Processes)
– System Implementation and Validation
– Implementation and Validation
– Globalisation
– Upgrade
– GAP Analysis (System and Processes)
PEC Support all eSubmission Regulatory Deliverables:
– eCTD : IND, NDA, BLA and lifecycle
– eCTD : MAA: National, DCP, MRP, Centralised, PSUR, ASMF, Baselines and lifecylce
– Support for all Regulatory submissions paper publishing

What are we looking for:
PEC offer solutions to life science companies who do have either have the expertise in-house or the software.

Collaboration sought:
  • Joint Venture Agreement


jasbir chohan

Director, Regulatory Operations
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