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Organizations and Regulatory Bodies

The American Medical Writers Association (AMWA), founded in 1940, is the leading professional organization for writers, editors, and other communicators of medical information. The association offers a highly regarded continuing education program, including distance learning and a certificate program. AMWA's mission is to promote excellence in medical communication and to provide educational resources in support of that goal.

The Brazilian Health Surveillance Agency (Anvisa) was created by Law 9782, enacted in 1999. It is a governmental regulatory agency characterized by its administrative independence, financial autonomy, and the stability of its directors. Anvisa is ruled by a Collegiate Board of Directors composed of five members.

The China Food and Drug Administration (CFDA) was founded on the basis of the former State Food and Drug Administration (SFDA). In March 2013, the regulatory body was rebranded and restructured as the China Food and Drug Administration, elevating it to a ministerial-level agency

Cochrane is a global independent network of health practitioners, researchers, patient advocates and others, responding to the challenge of making the vast amounts of evidence generated through research useful for informing decisions about health. It is a not-for-profit organisation with collaborators from over 120 countries working together to produce credible, accessible health information that is free from commercial sponsorship and other conflicts of interest.

CONSORT stands for Consolidated Standards of Reporting Trials and encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials. The main product of CONSORT is the CONSORT Statement, which is an evidence-based, minimum set of recommendations for reporting randomized trials. 

COPE is a forum for editors and publishers of peer reviewed journals to discuss all aspects of publication ethics. It also advises editors on how to handle cases of research and publication misconduct.

CSE is a dynamic community of editorial professionals dedicated to the responsible and effective communication of science. CSE is an international membership organization for editorial professionals publishing in the sciences. Our purpose is to serve over 800 members in the scientific, scientific publishing, ad information science communities by fostering networking, education, discussion, and exchange.

The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. It began operating in 1995.

EMWA is the European Medical Writers Association, a network of professionals that represents, supports and trains medical communicators in Europe. It is a not for-profit organisation that is run for its members by its members.

The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network is an international initiative that seeks to improve the reliability and value of published health research literature by promoting transparent and accurate reporting and wider use of robust reporting guidelines. It is the first coordinated attempt to tackle the problems of inadequate reporting systematically and on a global scale; it advances the work done by individual groups over the last 15 years.

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Health Canada is the Federal department responsible for helping Canadians maintain and improve their health, while respecting individual choices and circumstances.

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration.

The ICMJE is a small working group of general medical journal editors whose participants meet annually and fund their own work on the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals. The ICMJE invites comments on this document and suggestions for agenda items. The ICMJE participating journals and organizations and their representatives approved the revised Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals in August 2013.

The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 11 port offices and six laboratories under its control.

The goal of Informa Healthcare is to connect librarians, researchers and clinicians with information they can trust and use. Their 160+ journals include more than 3.5 million pages of high-quality research from 350,000 articles. Their portfolio of high end, peer-reviewed content from key opinion leaders covers disciplines across pharmaceutical research, life science and clinical medicine.

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan, and the US to discuss scientific and technical aspects of drug registration.

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) promotes the science of pharmacoeconomics (health economics) and outcomes research (the scientific discipline that evaluates the effect of health care interventions on patient well-being including clinical, economic, and patient-centered outcomes) and facilitates the translation of this research into useful information for health care decision makers to increase the efficiency, effectiveness, and fairness of health care to improve health.

Since its launch in 1948, the NHS has grown to become the world’s largest publicly funded health service. NHS Choices offers a wide range of resources that can support health care professionals in their work with patients and clients.

PMDA (Pharmaceuticals and Medical Devices Agency) is a Japanese regulatory agency, working together with Ministry of Health, Labor and Welfare. Their obligation is to protect the public health by assuring safety, efficacy, and quality of pharmaceuticals and medical devices.

PRISMA stands for Preferred Reporting Items for Systematic Reviews and Meta-Analyses. It is an evidence-based minimum set of items for reporting in systematic reviews and meta-analyses. The aim of the PRISMA Statement is to help authors report a wide array of systematic reviews to assess the benefits and harms of a health care intervention. PRISMA focuses on ways in which authors can ensure the transparent and complete reporting of systematic reviews and meta-analyses.

The Saudi Food and Drug Authority (SFDA) was established under the Council of Ministers resolution no (1) dated 07/01/1424 H, as an independent body corporate that directly reports to The President of Council of Ministers. The Authority objective is to ensure safety of food and drug for man and animal, and safety of biological and chemical substance as well as electronic products

The SQUIRE Guidelines help authors write excellent, usable articles about quality improvement in healthcare so that findings may be easily discovered and widely disseminated. The SQUIRE website supports high quality writing about improvement through listing available resources and discussions about the writing process.

The objective of the STARD initiative is to improve the accuracy and completeness of reporting of studies of diagnostic accuracy, to allow readers to assess the potential for bias in the study (internal validity) and to evaluate its generalisability (external validity). The STARD statement consists of a checklist of 25 items and recommends the use of a flow diagram which describe the design of the study and the flow of patients.

STROBE stands for an international, collaborative initiative of epidemiologists, methodologists, statisticians, researchers, and journal editors involved in the conduct and dissemination of observational studies, with the common aim of STrengthening the Reporting of OBservational studies in Epidemiology. The STROBE Statement is being endorsed by a growing number of biomedical journals.

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood, and blood products

The International Publication Planning Association (TIPPA) is an industry-run association. Our mission is to foster excellence in medical publications and communications within the biopharmaceutical industry by providing a foundation from which the industry can stand together to organize thoughts and present recommendations and ethical guidance. In addition, TIPPA provides practical strategies for developing, implementing and executing an effective publication and communication plan as a critical component of the clinical biopharmaceutical development process.

A global association of editors of peer-reviewed medical journals who seek to foster cooperation and communication among editors, improve editorial standards, promote professionalism in medical editing through education, self-criticism, and self-regulation, and encourage research on the principles and practice of medical editing.

The World Medical Association (WMA) is an international organization representing physicians. It was founded on 17 September 1947, when physicians from 27 different countries met at the First General Assembly of the WMA in Paris. The organization was created to ensure the independence of physicians, and to work for the highest possible standards of ethical behaviour and care by physicians, at all times. 

Famous Quotes

  • Few writers could equal the feat of Watson and Crick, who described the double helix (the molecular structure of nucleic acids) in 900 words, one table, and six references. Arthur Kornberg reported on the enzymatic synthesis of DNA in 430 words. Cournand and Ranges reported on the first catheterization of the human heart in 950 words. Fritz A. Lipmann described coenzyme A in 250 words, one table, and five references.
    Edith Schwager, in Medical English Usage and Abusage

  • First have something to say, 2nd say it, 3rd stop when you have said it, and finally give it an accurate title.
    John Shaw Billings

  • The cardinals in medical writing is not grammatical error but obscurity.
    Stanley Gilder, in Medical Journal of Australia, 1962

  • No passion in the world, no love or hate, is equal to the passion to change someone else’s draft.
    H. G. Wells

  • Editing is the most companionable form of education.
    Edward Weeks

  • Words and sentences are subjects of revision; paragraphs and whole compositions are subjects of prevision.
    Barrett Wendell

  • Writing is easy: all you do is sit staring at the blank sheet of paper [or your computer screen] until the drops of blood form on your forehead.
    Gene Fowler

  • The difference between the almost-right word & [sic] the right word is really a large matter—it’s the difference between the lightning bug and the lightning.
    Mark Twain

  • Never be satisfied with anything—everything can be done better than it is now being done.
    Eli Lilly,1926

  • In medical writing, there is no danger in being too precise—only in being imprecise.
    Edith Schwager

  • Few writers could equal the feat of Watson and Crick, who described the double helix (the molecular structure of nucleic acids) in 900 words, one table, and six references. Arthur Kornberg reported on the enzymatic synthesis of DNA in 430 words. Cournand and Ranges reported on the first catheterization of the human heart in 950 words. Fritz A. Lipmann described coenzyme A in 250 words, one table, and five references.
    Edith Schwager, in Medical English Usage and Abusage

  • Either write something worth reading or do something worth writing.
    Benjamin Franklin

  • If a writer knows enough about what he is writing about, he may omit things that he knows. The dignity of movement of an iceberg is due to only one ninth of it being above water.
    Ernest Hemingway

  • Quantity produces quality. If you only write a few things, you're doomed.
    Ray Bradbury

  • Writing is physical work. It's sweaty work. You just can't will yourself to become a good writer. You really have to work at it.
    Will Haygood

  • One hasn't become a writer until one has distilled writing into a habit, and that habit has been forced into an obsession. Writing has to be an obsession. It has to be something as organic, physiological and psychological as speaking or sleeping or eating.
    Niyi Osundare

  • Writing energy is like anything else. The more you put in, the more you get out.
    Richard Reeves

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