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Company

Pharmaceutical eConsulting

Street
21 Buckland Avenue
ZIP Code
SL3 7PJ
City
Berkshire
Country
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.
eCTD:
Submission Compilation
eCTD and Regional Guidance Consultation
GAP Analysis (System and Processes)
System Implementation and Validation
EDMS:
Implementation and Validation
Globalisation
Upgrade
GAP Analysis (System and Processes)

Profiltitel

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:
eCTD:
– 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
EDMS:
– 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
– NeeS: MAA, CTA, ROW
– 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


Responsible

jasbir chohan

Director, Regulatory Operations
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Participants

Enterprise Europe ScotlandAboleo LtdAccuro BiologicsAlliance BootsBeta TechnologyBitWiseFW Medical LLPInnova Partnerships LtdInterface-The knowledge connection for businessMarks and Clerk LLPMcClure Naismith LLPThe Medical Device Company LtdQuantics Consulting LtdScottish Health InnovationsPharmalinksSistemic LtdStrathclyde Institute of Medical DevicesSynthetic Nanomachines LtdTissue SolutionsUniversity of AberdeenEllis IP LtdPharmacells LtdCeltic CatalystsPharmaceutical eConsultingWeatherologyControlled TherapeuticsSphere Fluidics LimitedHighland Clinical Research FacilityMoorfields PharmaceuticalsEdinburgh Science Trianglebeocarta LtdRostiShore DesignPomBioTech GmbHIMG Innovations-Management  GmbH/ Enterprise Europe NetworkThe Eurotactics ConsultancyIBA GmbHSGS Life Science ServicesOnorach  ClinicalWideblueEnterprise Europe YorkshireAptuit ConsultingMosaigen/Endeavour CapitalEscubed LtdEulysis Ltd.Raumedic LtdCatalent Pharma SolutionsEscubed LtdUniversity of Aberdeen Research and InnovationSPRI - Basque Enterprise Europe NetworkLicentia LtdTake The WindRoslin CellabMoredun ScientificEnterprise Europe East of EnglandAvantiCell ScienceXeroshield Ltd.ImmunoSolv LimitedLeoben Research LimitedPRAXI / HELP-FORWARD Network &The Hellenic BioClusterEMBIO Diagnostics Ltd


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