For the past decade, we have worked with authors 1-on-1 or in small groups to take their documents to the next level – focusing key messages, creating transparent structure, and communicating complex technical information. We can help your authors so that readers at all levels, from scientific and engineering experts to generalist executives, can understand critical content with just one reading.
We have improved hundreds of documents in the pharma space – technical reports/assessments, performance qualification/process validations, SOPs/Work Instructions, eCTD modules, post approval submissions, transfer protocols – virtually the entire range of documents in your industry. And we’ve worked with documents dealing with small molecules, biologics, biosimilars, CAR-T therapy, and medical devices.
How we can help
We work with authors one-on-one or in small groups, either in person or remotely. Authors submit their draft documents in advance, and we conduct a thorough review. The we meet directly, with the document on the screen, and methodically work through the content, providing detailed guidance and concrete editorial suggestions that authors apply immediately
The result? Authors leave the session with a MUCH better document.
We can work with your firm on a per hour “as needed” basis or we can establish a retainer relationship where you can be assured regular access.