Medical writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products. As regulatory authorities expect precise, clear and well-written documents, any bad writing can raise health authorities queries and consequently delay product approval. Our professional team can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.
Our professional medical writers have an adequate understanding of medical, scientific and health terms and concepts, and the skills to translate such information into a variety of formats for different audiences. They are most commonly tasked with producing or assisting with the production of technical, informative, educational, or promotional medical content.
The Barrco Scientific/Medical Writing team has a thorough and technical knowledge and experience of all Common Technical Dossier (CTD) modules supporting marketing authorisation applications globally or in specific region (e.g., EMA and FDA). Our Scientific and Medical Writing experts regularly work in close collaboration with regulatory submission teams to develop the CTD modules in line with your registration strategy. Our scientific/medical writers have demonstrable CTD dossier writing expertise/experience and offer scientific writing services to support you with the following documents. For international market entry, the CTD (COMMON TECHNICAL DOSSIER) and the ACTD (ASEAN COMMON TECHNICAL DOSSIER) registration dossier files play an important role. We are experts in transferring your local registration dossier/file from Russia, China, Ukraine, Brazil, Mexico, Indonesia into CTD structure. We have supported many clients in generating an international regulatory strategy, including how to develop CTD standard registration files.
The need for medical writing in the pharmaceutical industry is increasing as companies develop more new drugs and medical devices, and various scientific documents need to be generated for submission to regulatory authorities during their approval process. Regulatory medical writing means creating the – huge – documentation that regulatory agencies require in the approval process for drugs, devices and biologics. All new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This demand for the clear articulation of medical science drives the demand for well written, standards-compliant documents that the regulators can easily and quickly navigate through (i.e. in Common Technical Document [CTD] format), read and understand. Medical writing as a function has become established especially in the pharmaceutical industry because the industry recognized that it requires special skill to produce well-structured documents that present information clearly and concisely.
We prepare the research and regulatory document:
Research documents:
– Clinical trial protocols
– Investigators′ Brochure
– Informed Consent Documents
– Study reports
– Research proposals
Regulatory Documents:
– Summary of Product Characteristics & Patient Information Leaflets
– Clinical study reports
– Subject narratives
– Regulatory submission documents, e.g. Common Technical Document (CTD) modules such as nonclinical and clinical overviews & summaries, expert reports, safety and efficacy summaries
– Safety reports, e.g. Periodic Safety Update Reports (PSURs), bridging reports, periodic benefit-risk evaluation report (PBRER), Development Safety Update Report (DSUR), Risk Management Plans etc.
– Disclosure of clinical results
