Regulatory writing essentially means developing various Regulatory documents for submission to Health Authorities (HAs). The documents must follow the relevant guidelines and convey the essential information accurately, transparently, and clearly to reviewers. Regulatory medical writers play a significant role in preparing documents and ensuring that they are accurate, concise, and compliant with the prevalent standards.…
- May 26, 2023 Pharmaceuticals, Regulatory Affairs, Regulatory Medical Writing
- May 25, 2023 Medical Devices
Introduction
Work instruction guides are written documents that provide you with clear and precise instructions on how to perform specific tasks or activities. They are designed to reduce the risk of failures, damages, or inconvenience that may result from improper execution.
- May 25, 2023 Medical Devices
A Performance Evaluation Report (PER) is a comprehensive clinical document that demonstrates the safety and performance of In Vitro Diagnostic (IVD) devices. It is mandatory for manufacturers to submit this document to place their IVDs in the European Union (EU) market. The PER is built on the foundation of the following three (03) pillars of data demonstration:
- May 25, 2023 Medical Devices
What is Staff Augmentation?
- May 25, 2023 Medical Devices, Regulatory Affairs
As we all know, to place an In Vitro Diagnostic (IVD) device in the European Union (EU) market, manufacturers must abide by the EU IVD Regulations (EU IVDR) 2017/746. One of the key requirements of the IVDR cycle is performance evaluation. The objective of performance evaluation is to demonstrate that the IVD is safe and effective to use, and at the same time, it is aligned with its intended use.
- May 25, 2023 Medical Devices, Regulatory Affairs
Clinical evaluation of medical devices is one of the key steps for receiving the Conformité Européenne (CE), or the European Conformity certification in the European Union (EU) geography.
- May 23, 2023 Pharmaceuticals, Regulatory Affairs
Introduction
The European Directorate for the Quality of Medicines and Healthcare recently announced an update on their (CEP) process, called promises to be more efficient, transparent, and user-friendly than its predecessor. In this blog, we will explore the benefits of and the role of Regulatory vendors in helping pharmaceutical companies navigate this new system.
Introduction
An abstract is a concise summary of a detailed work published separately from the main text. It should, therefore, stand out and be understood without referencing the complete details of the work. A conference abstract is a brief writing, often between two hundred (200) and three hundred (300) words, that serves at least three (03) distinct purposes as explained below.
- May 19, 2023 Pharmaceuticals, Regulatory Affairs
As a major step for the reproductive rights of women, Japan’s Health Ministry approves the first abortion pill in its history. Following multiple deliberations and debates over the controversial rules of consent, Japanese women are now allowed to seek safe abortions. It is also celebrated by medical experts online as an opportunity to increase better sex education and awareness.
- May 18, 2023 Medical Devices
In India, a medical device test license, issued by the Central Drugs Standard Control Organization (CDSCO),. is a license which allows the manufacturer to manufacture or import small quantity of medical device for the purpose of clinical investigations, tests, evaluations, demonstrations, or training and to gather data on its safety and efficacy.