Never miss these while writing the “Common Technical Document (CTD) for Pharmaceutical”
Medical Writing Experts
by Dr.Nancy
3y ago
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 gui ..read more
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Challenges in the CRO Industry: Selecting a CRO for your Research Trials
Medical Writing Experts
by Dr.Nancy
3y ago
Clinical Research Organization for Healthcare provides clinical-study and clinical-trial support for drugs and medical devices, wherein many pharmaceuticals, biotechnology, and medical device industries having operations in the Europe Union states outsource research services to CRO to increase efficiency and improve productivity. Clinical Research Organization | PEPGRA Contract Research Organization for Pharmaceutical Industry offer services such as Project, Data and Regulatory Management; Contracting; Medical Writing; and Site and Medical Monitoring, which offers the comprehensive benefits f ..read more
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Medical Editing “Tips and Techniques” before you hit “Publish”
Medical Writing Experts
by Dr.Nancy
3y ago
Go beyond general document editing skills A medical editor, who ensures the consistency of facts, data and scientific units and makes the manuscript clear and precise, should be technically meticulous more than general editing on spelling, grammar and punctuation errors in a manuscript. Medical Editing Services – PEPGRA Acquire basic knowledge of different medical specialties Medical terminology and concepts are profoundly complex and highly technical. So, Subject knowledge is must when editing technical documents related to different therapeutic areas such as Cardiovascular Critical Care De ..read more
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The Role of Referencing in Scientific Writing
Medical Writing Experts
by Dr.Nancy
3y ago
The Role of Referencing in Scientific Writing Scientific writing makes up an integral element within research. Of late, the pace at which findings of a research is communicated through diverse mediums such as thesis, books, conference papers and journal articles has substantially increased with widespread developments in technology and medicine. The findings from these researches are usually perceived as harbingers of development in the academic and scientific domain, driving further research or action. As is the case in any kind of academic writing, scientific writing too warrants the need f ..read more
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New MEDICAL DEVICE REGULATION(MDR): Top 5 Challenges
Medical Writing Experts
by Dr.Nancy
3y ago
Within the medical devices industry, professionals have long been exercising acquiescence with regards to the new European Medical Device Regulation (MDR). At last, after a very lengthy process the MDR was finalized and it was duly published in the Official Journal of the European Union on 5th May, 2017. With the passing of the new MDR, the previous regulations viz., the Active Implantable Medical Device Directive (90/385/EEC) as well as the Medical Device Directive has been totally replaced. The primary objective of the Revision of Medical Device Regulation is to ensure a regulatory framewor ..read more
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Writing for Medical Devices- a European consensus approach
Medical Writing Experts
by Dr.Nancy
3y ago
The requirements for medical writing are witnessing continuous growth influenced in good portion by the mounting government scrutiny and regulatory controls of companies manufacturing and marketing medical devices. The regulatory medical writer needs to possess basic abilities and proper understanding of the critical information about important regulatory checks and must be able to develop and present contents that conform to the regulatory requirements relating to medical devices.  The regulatory medical writer’s job is not all about producing and writing contents but also include good ..read more
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Writing a Biological Safety Assessment (BSA) report: Premarketing Requirement Risk Assessment
Medical Writing Experts
by Dr.Nancy
3y ago
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 ..read more
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Writing for Medical Device companies: The Role of Regulatory Medical Writers
Medical Writing Experts
by Dr.Nancy
3y ago
The term medical devices cover a wide range of medical equipment from common tongue depressors to highly sophisticated surgical and advanced diagnostic equipment that are used in various specialized medical disciplines.  These different types of equipment are extensively used in various sized hospitals ranging from rural health clinics to multi-specialty hospitals providing tertiary patient care. Similar to medicines and medical technologies, the medical devices are also highly essential for maintaining proper patient care. In this era of liberalization, medical devices are commonly impor ..read more
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Nuances of Scientific Medical Writing
Medical Writing Experts
by Dr.Nancy
3y ago
Scientific medical writing involves writing detailed information about the basic medical sciences, drugs and latest technological innovation in the field of medicine for a range of audiences including medical specialists and health care professionals. This scientific information is written for publication in the medical journals, medical news, and regulatory documents. The important role of scientific medical content writers is to develop high-quality technical materials for the scientific and medical community and disseminate the critical information regarding latest inventions, discoveries ..read more
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How to Become a Competent Medical Writer?
Medical Writing Experts
by Dr.Nancy
3y ago
Medical writing Service is a specialized area of writing where the medical writer needs to develop different types of scientific documents that include research related documents in the field of medical science and associated regulatory areas. The demand for competent, professional medical writers is growing at a rapid pace due to an exponential growth of pharmaceutical companies, diagnostic field and health care related portals, which require effective health care communication materials to promote their medicines, medical devices, related products and services to the doctors, patients and th ..read more
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