To view details of each case study, choose from the links below.
Case Study 1
Writing and reviewing several hundred case narratives from a large Phase III trial within a short timeframe.
Case Study 2
Providing expert regulatory advice and medical writing to a company preparing a clinical evaluation for its first medical device CE marking.
Case Study 3
Assembly of a team of experts to resolve stability issues and provide a clinical expert statement to support an urgently-needed variation.
Case Study 4
Complete overhaul of an old registration dossier into the full eCTD format to satisfy local authority requirements, through literature searching and medical writing support.
Case Study 5
Working with a company to prepare a UK formulary submission through gap analysis, guidance on submission requirements and writing a position paper to support the application.
Case Study 6
Preparation of a company for a Scientific Advice meeting with the EMA after conducting a literature search and writing a position paper.
Case Study 7
Assistance with a company’s first orphan drug application, through a disease area review, preparation and project management of the application.
Case Study 8
Working with a US company to prepare their first eCTD submission in Europe for a novel formulation with a new indication.
Case Study 9
Organisation and execution of readability testing of over 40 PILs for a large generics company within a tight timeframe.
Case Study 10
Provision of medical writing and project management support to a company with three NICE submissions with overlapping timelines.