10 CRUCIAL REASONS FOR OUTSOURCING MEDICAL WRITING

Medical writing outsourcing companies offer customized packages to the suitable requirements of medium and big sized companies, thereby presenting them various significant advantages to sustain and grown in the competitive medical communication domain. Professional medical writing companies consist of experienced professionals and experts in the highly specialized medical and writing field who can completely understand the diverse requirements of the companies requiring high-quality medical contents and medical writing assistance.

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NEVER MISS THESE WHILE WRITING THE “COMMON TECHNICAL DOCUMENT (CTD) FOR PHARMACEUTICAL”

Scientific Regulatory writing is a complex process due to its dossier size, data complexity, and submission deadlines and it requires specialized domain-specific knowledge, understanding of drug development process, pharmacology, statistical and writing skills to develop superior regulatory documents as per the exact requirements of the regulatory authority. Besides, the scientific writer must be familiar with technical guidelines prevailing in countries like European Union (EU), USA, Japan that includes ICH E3 to write clinical study reports, periodic safety reports (ICH E2C), publication guidelines (e.g. CONSORT, STROBE, PRISMA), the International Committee of Medical Journal Editors (ICMJE) guidelines for manuscripts. Common Technical Document(CTD) for Pharmaceutical The Common Technical Document (CTD) is an international standard for the summary documents relating to quality, safety and efficacy information of medicinal products. The CTD is mandatory for the registratio

MEDICAL WRITING FOR REGULATORY SUBMISSION IN CLINICAL RESEARCH AND ITS CHALLENGES

Regulatory medical writing in clinical trials requires medical writers to possess sufficient knowledge of the regulatory guidelines of concerned authorities of specific countries and needs to have dedication and commitment to handle large volumes of regulatory data. A professional regulatory writer needs to have sufficient understanding of the drug development process to determine the important documents that need to be written and submitted for regulatory submissions. Click Here to Read more

WRITING A BIOLOGICAL SAFETY ASSESSMENT (BSA) REPORT: PREMARKETING REQUIREMENT RISK ASSESSMENT

Biological Safety Assessment or BSA as it is called is an important and wide field. As new breakthroughs by way of medicine, crop, biotechnology increase, the need to assess the safety of medical devices becomes paramount. It provides some amount of reassurance to patients in a clinical investigation. A report should be based on medical devices directives -MEDDV 2.7.1 and clinical investigations guidelines ISO 14155. Writing a Biological Safety Assessment (BSA) report can run as under: 1 Clinical data and Evaluation and Evidence : The safety and/or performance information that is generated from the clinical use of a device and a procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device and an evaluation report pertaining to the medical device.

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