Medical Writing

In pharmaceutical drug development value is primarily generated by documentation. The saying is: “an experiment which is not documented is no experiment”.

We review your data and produce for you high-quality documents that meet your exact requirements and those of the regulatory authorities. Our services include:

Quality documentation

Non-clinical reports

Clinical Report

PSUR

Study protocols

Clinical study reports (Phases I to IV)

Common Technical Documents (CTD)

Clinical trial registry and database summaries

Clinical trial authorisations/investigational new drug applications

Summary of Product Characteristics

Patient Information Leaflets