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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.

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. Contact us at : IND:+91 8754446690 US:+1-972-502-9262 UK:+44-1143520021 info@pepgra.com www.pepgra.com

Tuberculosis or simply TB is a spreadable disease caused by Mycobacterium tuberculosis. This organism has a hard, waxy cell wall that makes it highly resistant to unfavorable environments and drugs. It evades the mucus lining of the windpipe and enters the lungs.

The goal of treating Tuberculosis is to protect the patient from possible disability and death. Another objective is to reduce the spread of Tuberculosis infection to others. TB may be a stubborn infection but with the right measures at the right time, it can be cured.

The US Food and Drug Administration (FDA) has issued a statement warning healthcare providers about potential complications in patients fitted with both programmable cerebrospinal fluid (CSF) shunt systems and certain magnetic hearing devices.

Any drug or pesticide that is made or extracted from parts of plants is referred to as botanical extracts. These extracts are 100% all-natural. They are usually extracted from plant sources; these include herbs and flowers, whose healing properties have been known since the earliest times. Today, they are used by alternative medicine practitioners to treat a wide range of medical conditions. Botanical extracts from these plants can be very effective as they help reduce appetite. The main reason is because they contain fatty acids that act as a signal to the brain telling it that the body has enough energy to burn fat but are not getting sufficient calories. Botanical extracts are concentrated plant materials providing therapeutic properties, which have been extracted through a variety of methods. When taken in conjunction with a healthy diet and regular exercise, these extracts may help lose weight. This is due to the fact that they cause the brain to think that the body is full and can now use some of its resources for other purposes, resulting in a decreased desire for food. When combined with certain other natural ingredients, extracts from these plants can also help to naturally boost metabolism so that it burns fat more efficiently. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/03/botanical-extracts-obtained-from-plants.html

Chronic lymphocytic leukemia is a cancerous disease in which cancer cells begin to multiply in the lymph cells. CLL is aggressive cancer that invades the lymphatic system and attacks healthy cells of the immune system. It typically affects the lymph nodes and T cells, although it can also affect any other cells in the human body. The combination of chemotherapy is aimed at destroying cancer cells while at the same time allowing the body's immune system to restore the damaged cells. This allows for a more rapid response to the infection and better overall outcomes. As a result of this combination, chemotherapy is often used to treat several types of cancer at one time. It has been very successful in achieving results against most types of cancer. The targeted drugs are given to make the cancer cells unable to multiply and thus stop their growth. Increasing prevalence of leukemia is expected to drive growth of the global chronic lymphocytic leukemia therapeutics market during the forecast period. According to the American Society of Clinical Oncology (ASCO), chronic lymphocytic leukemia (CLL) is the most common type of leukemia in adults aged 19 years and above with 37% of cases. According to the same source, around 21,040 new cases and 4,060 deaths are expected to occur in 2020 due to CLL in the U.S. Furthermore, according to the Leukemia & Lymphoma Society (LLC), in 2020, around 60,530 people are expected to be diagnosed with leukemia in the U.S. Such a high prevalence of CLL and leukemia has increased the demand for necessary therapeutics such as chemotherapy. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/chronic-lymphocytic-leukemia.html

Launch of new products is expected to propel growth of the metabolomics market. For instance, in January 2021, JUNO Metabolomics launched the JUNO Viral Surveillance Platform based on its proprietary AI-Based Informatics System. Similarly, in June 2019, Bruker Corp. presented mass spectrometry and Nuclear Magnetic Resonance systems and other solutions for molecular phenomics and clinical metabolomics research at Metabolomics 2019. Moreover, increasing prevalence of chronic disorders is also expected to aid in growth of the market. For instance, according to the American Cancer Society, in 2019, there will be an estimated 1,762,450 new cancer cases diagnosed and 606,880 cancer deaths in the U.S. Integration of Artificial Intelligence (AI) with metabolomics is expected to offer lucrative growth opportunities for players in the metabolomics market. For instance, in July 2020, ReviveMed, an AI-driven drug discovery platform, collaborated with Bristol Myers Squibb for an AI-driven metabolomics study that will leverage ReviveMed's AI platform to better understand mechanisms of response and resistance to immunotherapies in patients with cancer. Moreover, increasing demand for metabolomics is also expected to aid in growth of the market. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/integration-of-ai-with-metabolomics-and.html

Apheresis is an innovative medical procedure where the blood is extracted from the patient's body and then desired blood components (such as platelets, plasma, white cells, and red cells) are separated based on their weight and size. Depending on the cause of apheresis, one of these components is isolated and collected, while the other components are returned to the body. Apheresis is a blood purification procedure performed for blood donation component or for the treatment of disease. It is performed for various diseases such as hematological, autoimmune, renal, cardiovascular, neurological, and more. In apheresis procedure, the centrifuge therapeutic devices are used to separate desired blood components from the donor's blood. These blood components are separated based on their characteristics such as affinity for substance, molecular weight, and size among other factors. The emergence of COVID-19 is expected to propel the growth of the apheresis market. For instance, according to the Food and Drug Control Administration (Gujarat, India), there were 13 plasma apheresis units in the state before the pandemic, now the number has jumped to 28 to meet the requirement of plasma used in convalescent plasma therapy. Moreover, worldwide, as of 9:47am CET, 13 January 2021, there have been 90,054,813 confirmed cases of COVID-19, including 1,945,610 deaths, according to the World Health Organization (WHO). Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/emergence-of-covid-19-is-expected-to.html

Tissue Transplantation products and services are getting widely used in the healthcare sectors worldwide. The term Tissue Transplant refers to the process of adding new tissues to the body that is broken down and replaced by other organs or tissues. It is a major breakthrough in organ transplantation and is used more frequently. Tissue Transplantation is the practice of harvesting and replacing human organs such as kidneys, liver, heart valves, lungs, and bones with other healthy tissues from other people. Tissue Transplantation has given hope to many patients who have had to have a hip replaced or a kidney removed because of disease or illness. In recent years, there has been an increase in the number of people who are now choosing to donate their organs and tissues to medical research and treatment centers. More people are now aware of the need for organ donations and more people are now looking to give back to society than ever before. The demand for organ and tissue transplantation is increasing every day. Unhealthy food habits lack of exercise, drug abuse, and alcohol consumption results in organ failure, owing to which the demand for the Tissue Transplantation products and services market is estimated to rise. Increasing events of acute diseases are also estimated to aid the growth of the market. For instance, high blood pressure and diabetes are the main causes of end-stage renal diseases where kidney dialysis or transplant are the only options to save the patients. According to the U.S. Department of Health & Human Services, in 2019, there were approximately 122,913 patients in U.S. who needed urgent tissue transplants. Hence the increasing demand for advanced transplantation products is estimated to drive the market growth. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/the-global-tissue-transplantation.html

Gastroesophageal Reflux Disease (GERD) is a chronic condition that is characterized by the regurgitation of stomach contents into the throat. GERD is also known as acid reflux disease and it occurs in people of all ages. In milder cases, GERD can be effectively treated with simple pharmacological therapies or by altering a patient's diet. In more severe cases, esophageal surgery might be necessary to remove the troublesome esophageal sphincter and/or improve a patient's general physical condition. GERD can develop when the lower esophageal valve relaxes or becomes weakened. The diagnosis of GERD and gastroesophageal reflux disease can be done by examining the medical history and symptoms. Although acid-reflux disease typically affects the upper body, some of its symptoms can extend down the esophageal tract, making GERD particularly troubling for people who sit or stand for long periods of time. This problem has given rise to a variety of different approaches to treatment, including invasive, surgical treatments, non-surgical treatments and more novel, non-invasive therapeutic approaches. The latest treatment option on the table involves using pharmaceuticals, such as selective serotonin reuptake inhibitors (SSRIs), to help reduce the effects of GERD. There are a number of advantages to this strategy. For starters, SSRIs are believed to have numerous side effects that tend to make them less attractive to certain groups of patients. Electrical stimulation (ESD) is another common form Gastroesophageal Reflux Disease (GERD) Treatment Devices. This technique involves the use of electrodes attached to the esophageal wall to generate a varying amount of electrical current. Antirheumatic drugs, which often cause symptoms similar to those of severe heart disease, are sometimes added to the mixture. A major disadvantage of using plicator devices with ESD is that the procedure can only be performed on an outpatient basis, requiring a patient to remain in the hospital for a fe

A gynecological device is a medical device that is used to promote female health or to protect and preserve reproductive health for females. This is a very broad category and includes products such as watches, calculators, bandages, and hygienic towels. While many of these products have been clinically tested and found to be safe for female health, there are still a few devices in the market that pose threats to female reproductive health. Gynecological devices usually fall into three categories: medical devices, biological safety devices, and mechanical devices. Medical devices are those that prevent the risk of injury or trauma to a woman's reproductive organs from medical interventions. Biologic safety devices are those that protect a female's health by promoting female reproductive health. Finally, mechanical devices are those that help maintain a woman's reproductive health and allow her to achieve or reach their desired fertility or pregnancy. The use of any of these unsupervised or unsafe medical procedures poses a risk to a woman's reproductive health and should be avoided at all costs. The main factors driving the growth of the gynecological devices market are the rapid increase of gynecological diseases such as uterine fibroids, endometriosis, and vaginitis and the introduction of new innovative gynecological devices in the market. For instance, according to the U.S. National Center for Biotechnology Information, approximately 97 per 1000 women suffer from gynecological diseases in the U.S., among which approximately 53 per 1000 women suffer from menstrual disorders. Rising awareness about gynecological health and preventive check-up to avoid sexually transmitted diseases (STD) is expected to boost the market growth. Moreover soaring numbers of surgical procedures such as female sterilization, endoscopy, laparoscopy, and ablation are driving the demand for gynecological devices. However strict regulatory orders by governmental bodies across the globe rel

Biosimilars, also known as biologic products, are currently the fastest growing category of medical products in the United States, with sales estimated at more than $40 billion dollars annually. When prescribed by doctors, these products may provide more effective treatment options for patients suffering from a chronic disease or condition. In late August, the FDA held a forum on biosimilars. The topic was "biosimilar medications - what are they, how do they work, and are they safe and effective." Representatives from the FDA, pharmaceutical companies, and biotechnology organizations attended the forum. The forum included individuals who are leading the charge to register biosimilar products for clinical trials. According to the FDA, the agency will begin accepting applications for biologic drugs in late fall of 2020. In Japan, various manufacturers are focused on developing pipelines that contain biosimilar candidates aimed at treating various therapeutic conditions for patients in Japan. For instance, in December 2020, Alvotech and Japanese pharmaceutical company Fuji Pharma agreed on an extension on their exclusive strategic partnership for the commercialization of four biosimilar medicines in Japan. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/biosimilars-and-impact-of-covid-19.html

Protein A colorimetric resins are the most extensively used affinity purifiers in bio-manufacturing and other industries. Protein A colorimetry is a robust, high-throughput chromatography method and is used primarily as a capture step because of its inherent precision. Approval and launch of new biosimilars is expected to propel growth of the protein A resin market. For instance, in December 2020, Sandoz Canada Inc., a generics and biosimilars manufacturer and a division of the Switzerland-based multinational Novartis AG, received Health Canada authorization for Hyrimoz (adalimumab injection, reference biologic drug: Humira) on November 4, 2020 for marketing in Canada. Hyrimoz, the new biosimilar, has been approved for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, hidradenitis suppurativa, psoriasis and adult uveitis. Moreover, high prevalence of chronic diseases is also expected to aid in growth of the protein A resin market. For instance, according to the American Cancer Society, in 2019, there will be an estimated 1,762,450 new cancer cases diagnosed and 606,880 cancer deaths in the U.S. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/emergence-of-covid-19-to-offer_23.html

Decline birth rate worldwide has led to the increasing adoption of various human reproductive technologies. For instance, according to the World Bank, Japan's birth rate, crude (per 1,000 people) decreased from 8.413 in 2005 to 7.4 in 2018. On the other hand, the increasing population has also led to the approval and launch of contraception products. In May 2020, Evofem Biosciences, Inc. received the U.S. Food and Drug Administration (FDA) approval for Phexxi (lactic acid, citric acid and potassium bitartrate) vaginal gel used to prevent pregnancy in females of reproductive potential for use as an on-demand method of contraception. As the use of human reproductive technologies advances, there is increasing concern about ethical issues surrounding these medical interventions. While the use of fertility medication has been approved by the FDA, there are still questions about how to regulate it because of the fact that it is not a prescription and because of the inherent risks associated with using the technology. The first thing that we need to recognize is that the technology of artificial insemination has been around for decades. The only difference today is that we now have the ability to use technology to assist in the process of getting pregnant. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/01/declining-birth-rate-and-increasing.html

Forensic pathology is the application of clinical medical jurisprudence in forensic medicine. A forensic pathology specialist is a physician who has completed a residency in molecular biology, pathology, and related disciplines and has then specialized in forensic pathology as a post-graduate program. The standards for being a "fully certified" forensic pathology specialist vary from state to state. There are also national accreditation programs that offer associates or bachelor's degrees for forensic pathology specialists. Forensic pathology can be applied to a wide range of situations, such as drug and alcohol abuse, homicide and other crimes, sexual assault, and sexual motivation. Forensic pathology specialists can analyze tissue samples to examine for disease, and they use various methods to determine the cause of death, cause of trauma, etc. For instance, gas chromatography is used in the forensic pathology for analyzing fibers on the body. Moreover it also used to analyze blood found at a crime scene. There are many types of forensic pathology, and each type involves different techniques and terminology. Some examples include: pathology of blood and other bodily fluids; pathology of sexually transmitted diseases; pathology of trauma; pathology of forensic genitourinary and obstetric disorders; pathology of traumatic and infectious diseases; pathology of unidentified remains. Read More @ https://www.blogger.com/blog/post/edit/preview/9197580861156902959/6381348933167984177

Gouty arthritis is a type of arthritis that causes inflammation, typically in one joint, which begins suddenly. Gouty arthritis is caused by the deposition of needle-shaped crystals of uric acid in a joint. The primary symptoms of gouty arthritis include severe pain, swelling, and redness in joints, often in the big toe. Increasing prevalence of gout with rising alcohol consumption is expected to drive growth of the global gouty arthritis market. According to the Centers for Disease Control and Prevention (CDC), from 2013-2015 around 54.4 million adults in the U.S. have some form of arthritis, gout, rheumatoid arthritis, or fibromyalgia. According to the Arthritis Foundation, 8 million people in the U.S. suffer from gout arthritis every year. According to the same source, high intake of sugary or alcoholic drinks is one of the major risk factors for gout arthritis. Alcohol is a major source of purine, which produces uric acid. High levels of uric acids in the body can result in the formation of crystals of uric acid, eventually leading to gout. Hence, such factors are expected to drugs market is expected to drive growth of the global gouty arthritis market. Furthermore, increasing adoption of biologics and increasing R&D activities in regenerative medicines is expected to propel the global gouty arthritis market growth in the near future. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/gouty-arthritis-market-is-gaining.html

Micro guide catheters are used in order to guide the urethra so that you can have an easy time inserting your pet's urethra and not be worried about any kind of blockage at all. There are many types of these devices available in the market. Some of these are manual tube and electric as well. Many people prefer to use micro guide catheters because they are made very simple and with great ease of use. A growing number of surgical procedures for treating cardiovascular diseases is fueling the growth of the micro guide catheters market. According to the American College of Cardiology Foundation, in 2017, emergency medical services-assessed out-of-hospital cardiac arrest occurred in an estimated 356,461 Americans; emergency medical services treatment was initiated in 52%. In the United States in 2019, coronary events are expected to occur in about 1,055,000 individuals, including 720,000 new and 335,000 recurrent coronary events. The increasing development of modern disposable catheters that are safer and more comfortable to insert is further projected to foster the growth of the micro guide catheters market. North America is projected to gain significant growth over the forecast period and this is attributed to the continuous launch of innovative products by ley players in the region. For instance, in March 2017, Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and the U.S. commercial launch of the TrapLiner Catheter. The TrapLiner Catheter was developed by Vascular Solutions Inc., which was acquired by Teleflex. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/rise-in-number-of-cardiovascular.html

Medical ceramics are ceramics that have the properties to be used as the direct medium of medical procedures. They are made from a number of different materials including porcelain, enamel, ceramic, polymers, and other materials. The ceramic material is used to serve the purpose of impregnating the substances on the affected part so that they get affected by the required heat and are changed into a non-toxic and safe substance. Increasing demand for implantable devices is expected to drive the growth of the global medical ceramics market. The demand for implantable devices offer additional advantages including the ability to selectively activate grouping of fibers within the nerve. Major companies operating in the market are focused on research and development activities, in order to gain a significant edge in the competition. For instance, in December 2020, W. L. Gore and Associates, Inc. received the U.S. Food and Drug Administration (FDA) approval for its Gore Excluder Comfortable (EXCC) AAA Endoprosthesis to treat patients with aneurysm of the infrarenal abdominal aorta. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/medical-ceramics-market-is-expanding.html

Chronic renal failure, or renal overload, is associated with a variety of morbidity and mortality and is a major challenge in the clinical treatment of patients with chronic renal failure. This disease has no cure and can be managed with specific medications in an appropriate course of therapy. However, in patients for whom other therapies have been ineffective or who are experiencing life-threatening side effects, continuous renal substitute therapy (CRS) is the only feasible treatment. Continuous Renal Replacement Therapy (CRRT) is a type of blood purification therapy used in the treatment of patients with acute kidney injury. The therapy is commonly used to provide renal support for critically ill patients with acute kidney injury, particularly patients who are hemodynamically unstable. Emergence of COVID-19 has led to increasing adoption of CRRT as patients with Covid-19 are experiencing multiple organ failure, including acute kidney injury. Moreover, regulatory bodies are also focused on approval and launch of new CRRT devices. For instance, in April 2020, The U.S. Food and Drug Administration granted marketing authorization for a new device indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms (or 5.5 to 22 pounds). Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/demand-for-continuous-renal-replacement.html