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eCTD/CTD/NeeS Publishing solution
  • Home
  • About us
    • Company Overview
    • Testimonials
  • Services
    • Overview
    • Regulatory submissions
      • eCTD
      • Drug Master File (DMF)
      • Active Substance Master File (ASMF)/CEP
      • NeeS
      • SPL R4
      • Periodic Adverse Drug Experiences Report (PADER)
    • Regulatory services
  • Solutions
    • eCTD publishing & submission
    • NeeS publishing & submission
    • CTD/Paper publishing & submission
    • Regulatory Information Management System (RIMS)
    • eCTD viewer
    • eCTD submission on-cloud
    • Query Management (QM)
  • Compliance
  • Knowledge Bank
    • Blog
    • Webinar
    • Regulatory links
  • Contact us

Regulatory links

  • Home
  • Knowledge Bank
  • Regulatory links

Download material on various topics from our Knowledge Bank.

Get direct links to important regulatory agencies and informative webpages/websites. Get latest information related to your area of interest by mailing us Email us at enquiry@knowledgenet.in

Downloads

  • PDF specifications for Regulatory Submission

Useful Links

  • U S Food and Drug Administration (US FDA)
  • Postmarket Drug Safety Information for Patients and Providers
  • CFR 21 Search
  • Drugs @ FDA
  • Electronic Orange Book
  • CDER Guidance Documents
  • Electronic Submission Gateway
  • FDA Forms
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
  • ICH Guidelines
  • ICH eCTD
  • European Medicines Agency (EMA)
  • EudraVigilance Medicinal Product Dictionary
  • Therapeutic Goods Administration (TGA) | Australian Government Department of Health
  • Jordan Food and Drug
  • Regulatory Affairs Professionals Society (RAPS)
  • Parental Drug Association (PDA)
  • Drug Information Association (DIA)
  • Drug, Chemical and Associated Technologies Association(DCAT)
  • DailyMed – Current Medication Information
  • Health Canada
  • GCC-region (SFDA)
  • Swissmedic (Switzerland)
  • South Africa (SAHPRA)
  • Thailand
  • Electronic Medicine Compendial (EMC)

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