Case Studies
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.
Writing and Preparing Case Narratives
Case Study 2
Providing expert regulatory advice and medical writing to a company preparing a clinical evaluation for its first medical device CE marking.
Medical Device Clinical Evaluation
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.
Updating Clinical Components of the CTD
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.
Preparation of a Formulary Submission
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.
Gaining Orphan Drug Designation
Case Study 8
Working with a US company to prepare their first eCTD submission in Europe for a novel formulation with a new indication.
eCTD Conversion and Submission
Case Study 9
Organisation and execution of readability testing of over 40 PILs for a large generics company within a tight timeframe.
Portfolio Management for PIL User Testing
Case Study 10
Provision of medical writing and project management support to a company with three NICE submissions with overlapping timelines.
