PEPGRA HEALTHCARE Private Limited

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

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 for pharmaceutical companies in Europe Union to make clinical research trials more efficient and cost-effective in testing economic period. CRO   industry Challenges The CRO faces multifaceted challenges in the form of Increasingly becoming complex nature of regulatory requirements, GxP compliance, and quality. High levels of risk associated with the CRO business model Increa

G o 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 A cquire 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 Dermatology Endocrine Gastroenterology Hematology & Oncology Immunology Infectious Diseases Neuroscience Ophthalmology Rare Diseases Respiratory Urology Vaccine Development However, as it may not be possible for an editor to have knowledge in different areas, a medical editor should acquire basic knowledge in different therapeutic areas with related sc

The Role of Referencing in Scientific Writing Referencing can be considered as a systematic and scientific technique to define a source of data by presenting a set of information that facilitates a particular text to be easily identified, sought and retrieved. Though referencing would specifically refer to information sources that are included within a scientific paper, the detailed list of sources is presented within the bibliography. There are several styles of referencing that have been in use in the medical, scientific and other domains which would include:- Vancouver The Harvard and APA referencing styles would comprise of including the name of the author and the year of publication while the Vancouver style involves the use of numbers to denote a reference. APA ( American Psychological Association ) Harvard University The Problems The increased number of diverse fields of data for every single material that can be cited often gives rise to re

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 imported in developing countries, which potentially increase the chances of unscrupulous commercial elements causing significant concerns for the safety of patients on whom the inferior quality devices are used. To avoid this, all the main countries have established or follow global standard regulatory control  guidelines for medical devices  to prevent the use of substandard equipment, thereby minimi

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.

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 framework  that is sustainable, forceful, foreseeable and clear which is essential for ensuring that the level of safety is extremely high within the healthcare sector and at the same time fosters innovation Guidance to  Medical Device Regulations in Europe To highlight the key modifications that have been effected by the new MDR and to resolve these issues, the top five hurdl