Knowledge Bank

Download material on various topics from our Knowledge Bank.

Get direct links to important regulatory and informative webpages/websites. Get latest information related to your area of interest by mailing us...
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Downloads

• Bookmarking and Hyperlinking (eCTD)
• Guidelines to Use PDF (eCTD)

Useful Links

• U S Food and Drug Administration (US FDA)
• • postmarket Drug Safety Information for Patients and Providers
  • Federal Register
  • CFR Search
  • Drugs @ FDA
  • Electronic Orange Book
  • CDER Guidance Documents
  • Electronic Submission Gateway
  • FDA Forms
• American Association of Pharmaceutical Scientists (AAPS)
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
• • ICH Guidelines
  • ICH eCTD
• European Medicines Agency (EMEA)
• • Pharmacovigilance in European Economic area
  • EudraVigilance Medicinal Product Dictionary
  • Pharmacovigilance guidelines
  • EMEA - Europe, the Middle East and Africa
• Regulatory Affairs Professionals Society (RAPS)
• Parental Drug Association (PDA)
• Drug Information Association (DIA)
• Drug, Chemical and Associated Technologies Association (DCAT)
• DailyMed - Current Medication Information
• 21 CFR Part 11 compliance reference
• Wikipedia - Title 21 CFR Part 11
• SPL XML Schema

Client Testimonial

Of the handful of options available for internally hosted eCTD solutions, Sarjen System’s KnowledgeNet is a smartly designed interface with an attractive price and the least infrastructure...

Mr. Sree Vadlamudi

(using eCTD Dossier Life cycle)

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