BooksBooks

Key Regulatory Topics: eCTD

Member: $87.50 Nonmember: $112.50
Key Regulatory Topics: eCTD

>> View Table of Contents

The process of compiling your electronic Common Technical Document (eCTD) can be overwhelming, but—with RAPS’ on your side—you know that you’ll have a competitive advantage.

Featuring guidance documents from the International Conference on Harmonization, European Medicines Agency and the US Food and Drug Administration, Key Regulatory Topics: eCTD keeps you on the cutting edge of regulatory.

Who should use this publication?

Newcomers and experienced regulatory professionals will find value in the eCTD guide. It provides a solid background in the basics of compiling your eCTD while also containing a wealth of information for experienced pros seeking answers to specialized questions.

Add Book to Cart
 

Discover more of what matters to you

APIs Audit/FDA Inspection Biologics Biotechnology Chemistry, Manufacturing and Controls (CMC) Combination Products Compliance Diagnostics Global Nutritional/Natural Health OTC Other Pharmaceuticals Quality Assurance and Control Regulatory Intelligence/Policy

News »

  2;4;5;6;7;9;10;11;16;21;23;24;25;30;31;