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Pharmalicensing | Life Science's Global Technology Marketplace
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Regulatory Affairs Services
ELC GROUP S.r.o. Czech Republic flag Czech Republic
Abstract ID:
Regulatory Affairs services include handling technical and publishing projects for Global Regulatory Markets....
Contact Rishi Jacob
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•    Pre-Clinical/ Clinical Submission Plan
•    Submission Management (Electronic, Paper, eCTD and NeeS)
•    Dossier Authoring (M1 to M5)
•    Marketing Applications IND, NDA, ANDA Submission filing
•    Product Labelling Management
•    Life Cycle Management – Product Registration Management, CMC Variations
•    Post Marketing – Tracking PMC commitment deadlines (tool), protocol creation, annual report creation, file final study reports.
•    Regulatory data and document maintenance process
•    Redaction
•    Readability Testing
•    Translations

eCTD services include:
•    Conversion of NTA to CTD & CTD to eCTD
•    Conversion of NeeS to eCTD
•    eCTD publishing for EU, US
•    Publishing of lifecycle management
•    For US Only
•    SPL Publishing
•    STF publishing

FEATURED
Last Updated Jun 2016
Technology Type
Phase of Development
CORPORATION