Medical and regulatory writing: an overview

Medical and regulatory writing are essential aspects of communication in the healthcare industry, especially in science and in the development and authorisation of drugs and medical devices.

These types of writing play a crucial role in scientific publications and in the preparation of documents required for submission to ethics committees and health authorities.

Medical writing

Medical writing involves the creation of documents that communicate scientific information clearly and precisely. This includes specialist articles, abstracts from specialist conferences, clinical study reports and patient information. The objective is to present complex scientific and medical data in an understandable way in order to inform both experts and laypersons.

Regulatory writing

Regulatory writing is a specialised area of medical writing that focuses on the preparation of documents that are submitted to health authorities. These documents must comply with the relevant guidelines and convey the required information accurately, transparently and clearly to the target audience, which usually consists of investigators at the health authorities. Regulatory authors are responsible for the creation and organisation of documents that support the approval process of medicinal products and medical devices. These include clinical study reports, clinical investigation plans, investigator brochures and safety reports. These documents are crucial for the assessment of a product's safety and effectiveness by authorities.

Core competences and skills

Regulatory writers must have a sound knowledge of regulatory requirements and best practice. They should be able to analyse and interpret complex scientific information in order to present it in an understandable form. In addition, "soft" skills such as project management, collaboration and diplomacy are crucial, as regulatory writing often takes place in a team-oriented environment.

Challenges and training

Although regulatory writing is a growing field with many opportunities, there are few formal training opportunities. Successful regulatory writers require a combination of technical knowledge and practical experience. National and international organisations offer training to help aspiring authors get started in this field and for experienced authors to continuously improve. Overall, medical and regulatory writing are essential components of healthcare to ensure that important scientific findings are communicated effectively and regulatory requirements are met.

MEDIACC helps medical device manufacturers achieve reimbursement eligibility for their products by developing customised study designs that demonstrate the medical benefits and safety of the products. This includes the writing of study concepts, the preparation of study documents and the preparation of clinical study reports for authorities. The concepts are not only scientifically sound and regulatory compliant, but also include the development and documentation of modern and innovative processes and procedures for completely digital clinical investigations. This also includes the utilisation of results and the international presentation of study results in high-ranking specialist publications or at national and international congresses of specialist societies.

May we also support you? You are welcome to arrange a first non-binding appointment here.

Medical and regulatory writing are essential aspects of communication in the healthcare industry, especially in science and in the development and authorisation of drugs and medical devices. These types of writing play a crucial role in scientific publications and in the preparation of documents required for submission to ethics committees and health authorities. Medical writing Medical writing involves the creation of documents that communicate scientific information clearly and precisely. This includes specialist articles, abstracts from specialist conferences, clinical study reports and patient information. The objective is to present complex scientific and medical data in an understandable way in order to inform both experts and laypersons. Regulatory writing Regulatory writing is a specialised area of medical writing that focuses on the preparation of documents that are submitted to health authorities. These documents must comply with the relevant guidelines and convey the required information accurately, transparently and clearly to the target audience, which usually consists of investigators at the health authorities. Regulatory authors are responsible for the creation and organisation of documents that support the approval process of medicinal products and medical devices. These include clinical study reports, clinical investigation plans, investigator brochures and safety reports. These documents are crucial for the assessment of a product's safety and effectiveness by authorities. Core competences and skills Regulatory writers must have a sound knowledge of regulatory requirements and best practice. They should be able to analyse and interpret complex scientific information in order to present it in an understandable form. In addition, "soft" skills such as project management, collaboration and diplomacy are crucial, as regulatory writing often takes place in a team-oriented environment. Challenges and training Although regulatory writing is a growing field with many opportunities, there are few formal training opportunities. Successful regulatory writers require a combination of technical knowledge and practical experience. National and international organisations offer training to help aspiring authors get started in this field and for experienced authors to continuously improve. Overall, medical and regulatory writing are essential components of healthcare to ensure that important scientific findings are communicated effectively and regulatory requirements are met. MEDIACC helps medical device manufacturers achieve reimbursement eligibility for their products by developing customised study designs that demonstrate the medical benefits and safety of the products. This includes the writing of study concepts, the preparation of study documents and the preparation of clinical study reports for authorities. The concepts are not only scientifically sound and regulatory compliant, but also include the development and documentation of modern and innovative processes and procedures for completely digital clinical investigations. This also includes the utilisation of results and the international presentation of study results in high-ranking specialist publications or at national and international congresses of specialist societies. May we also support you? You are welcome to arrange a first non-binding appointment here.