Regulatory medical writing

A team of experienced medical scientists write all your documents for research, evaluation, scientific publishing and marketing authorisation application.

Study documents

We write all your study documents, from design to reporting, including: synopses, protocols, case-report forms, information and consent forms, study reports, as well as documents for regulatory applications.

Thoroughly familiar with applicable international standards and with the European regulatory framework and experienced in the whole study process. This allows us to anticipate difficulties and avoid pitfalls.

Marketing authorisation applications

We prepare your Common Technical Documents (CTD), whether those are based on original research or on bibliographic review. We especially write sections 2.5 (Clinical overview), 2.7 (Clinical summary) and module 5 (Clinical study reports).

We also prepare simplified applications, for instance for generic drugs or amendment of an existing authorisation, and Summaries of product characteristics.

Let clinical evidence
support innovation

Applications

News

Morning Read: Non-profit designing free Wi-Fi architecture for hospitals >> Read

Managing retinal vein occlusion >> Read

Let Me Die on the Prairie by Frances Jane Crosby Van Alstyne >> Read

Publication: Volume 16, number 4 (Stevenson). Study found that no conclusive results can be provided on the cost-effectiveness of four non-invasive tests for liver fibrosis [the Enhanced Liver Fibrosis Test, FibroTest and FibroMAX and transient elastography (FibroScan)] in patients suspected of having alcohol-related liver disease. >> Read

Top headlines from HIMSS2012 (Tuesday edition) >> Read

Incidence of diabetic retinopathy in people with type 2 diabetes mellitus attending the Diabetic Retinopathy Screening Service for Wales: retrospective analysis >> Read

Publication: Volume 16, number 3 (Hockenhull). Report finds that whilst some interventions targeted at mental health populations to reduce violence are well supported by the evidence a scattergun approach in the research literature provides little firm evidence for the majority of interventions. Evidence shows small-to-moderate effects for cognitive behavioural therapy for psychological interventions, and larger effects for atypical antipsychotic drugs. >> Read

How the NHS measures up to other health systems >> Read

Publication: Volume 16, number 5 (Ara). Although orlistat, sibutramine and rimonabant are all effective at reducing weight and body mass index and, compared with placebo, are all cost-effective, both sibutramine and rimonabant have been withdrawn because of safety concerns relating to potential treatment-induced fatal adverse events. >> Read

Peter John Fenton >> Read

Publication: Volume 16, number 6 (Reeves). The verteporfin photodynamic therapy cohort study found that treatment and follow-up were much less frequent in routine clinical practice than in research trials and the cost-effectiveness was similar to the highest previous estimate. >> Read

Frederick Valentine Flynn >> Read