Trust DRA to make sure that you have the clinical and non-clinical documentation needed for successful applications and fast market access. We will prepare all the documentation for you, including clinical and non-clinical writing for pharmaceutical products, summaries, overviews and applications in CTD format.
Our clinical and non-clinical services for pharmaceuticals include:
- Product information (PI) translations and updates (SmPC, PL, labelling)
- Risk management materials (RMP), Direct Healthcare Professional Communication (DHPC) documents
- Marketing materials, web pages, Standard Operating Procedures (SOPs)
- Educational materials, articles, clinical trial documentation
- Review of texts and factual content (medical review, linguistic review, quality review).
Ask DRA to handle the clinical and non-clinical writing for your pharmaceutical products, including plans, applications, reports and dossiers. Ensure a successful application process and fast market access with complete and accurate clinical and non-clinical documentation. Our highly trained team can take care of all aspects of this documentation for you, while making sure that the facts and figures are accurate down to the smallest detail.
Our services include preparing medical texts, medical translations, updates and proofreading. Our expert team combines fluent language skills with medical and pharmacological expertise, as well as knowledge of administrative regulations, official guidelines and Quality Review Document (QRD) templates. We can also help you with medical content and marketing compliance reviews. In addition, our team will use the correct style of language to reach your target audience and to support your positive corporate image.
Biological medicines: how does their manufacturing process differ from traditional medicines?
The differences in the manufacturing process and the nature of the active substance itself mean that biologicals differ from traditional medicines in many ways.
EU Council to postpone the MDR deadlines
The commission’s plan would not automatically apply an extended transitional period for all the medical devices, but the extension would be allowed on the condition that it is critical for the safety of the patients.