As regulatory landscapes evolve, countries worldwide are embracing the adoption of electronic Common Technical Document (eCTD) submissions to streamline their Regulatory submissions processes. One such country that will soon be venturing into the realm of eCTD submissions is Singapore.
- June 5, 2023 Publishing & Submissions, Regulatory Software & Services
- June 1, 2023 Cosmetics Regulatory Services, Regulatory Affairs, Regulatory Labeling
The European Union (EU) is a political and economic union of 27-member states located primarily in Europe. It represents one of the largest economic areas in the world, with a population of over 748 million people. One of the most significant challenges for businesses operating in the EU is dealing with the many different languages spoken across the region.
- June 1, 2023 Chemicals, Consumer Healthcare, Regulatory Affairs
Malaysia has established several chemical safety regulations to protect human health and the environment from potential hazards associated with the use, handling, storage, and disposal of hazardous chemicals. This blog provides an overview of the key chemical safety regulations that are currently in place in Malaysia.
Unlocking the potential of a ground-breaking pharmaceutical product requires meticulous attention to detail, especially when it comes to artwork management. In the ever-evolving landscape of regulatory compliance, where success hinges on flawless execution, there is no room for error. But why Right-First-Time Artwork?
- May 30, 2023 Medical Devices
Reprocessing refers to the method through which you can reuse medical devices safely and effectively.
- May 30, 2023 Medical Devices
The European Union Medical Device Regulation (EU MDR) has replaced the Medical Device Directive (MDD) and the Active Implantable Medical Device Directives (AIMDD), introducing several significant changes in the regulations. One of the key elements that has been replaced is Essential Requirements (ER). ER have now been replaced by General Safety and Performance Requirements (GSPR).
- May 26, 2023 Pharmacovigilance, Pharmaceuticals, Regulatory Affairs
The COVID-19 pandemic has brought about unprecedented changes in the healthcare industry, including the Pharmacovigilance (PV) process. The pandemic re-emphasized the role of PV in the pharmaceutical industry. As personalized medicine gained popularity, the tactics of pharmaceutical manufacturers and the PV process flow for ensuring the end-user’s safety had to alter.
- May 26, 2023 Pharmaceuticals, Compliance, Audit and Validation, Regulatory Affairs
The expanding global footprint of pharmaceutical manufacturers brings about great opportunities, but it's not without the challenges faced by pharma companies in drug development. Compliance hurdles in emerging markets are causing a stir.
- May 26, 2023 Pharmaceuticals, Regulatory Affairs, Regulatory Medical Writing
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 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.