The Gray Book is a medicines development e-text hyperlinked to regulatory guidelines. 

18 chapters covering each area of development.

Summary versions of the text are available in English, German, French, Japanese ad Chinese.

Supplementary materials are available to order separately as follows:

1. Spreadsheet based tools for developers: 

Target product and core profile templates, issue identifier for diligence, key activity and action plan templates, development cost worksheet, NPV calculator , tox drug substance calculator, development plan scenario builder, go/no-go decision tracker, competitor table, recruitment tracker, upside identifier

2. Introductory Course

6-Module course, based on the Base Text with additional online videos and MCQs and answers to ensure learning. Approximately 24 hours of study.Certificate of completion after passing final exam MCQ.

3. Full idea to market case study - small molecule and monoclonal antibody

A complete example of development of a small molecule and monoclonal antibody with accompanying key documents and time and costs. A unique way to rapidly understand how the theory of development is translated into practice.

Please use the contact form for further information.