Malaysia’s food and dietary supplements market is witnessing exciting new developments, driven by growing consumer demand for health and wellness products. As more and more people embrace a proactive approach to their well-being, the industry responds with innovative launches and diverse offerings.
- July 10, 2023 Food and Food Supplements, Regulatory Affairs
- July 6, 2023 Pharmaceuticals, Regulatory Labeling
The pharmaceutical industry operates in a highly regulated environment, with stringent labeling requirements and information dissemination. As pharmaceutical companies strive to meet the diverse needs of patients and healthcare professionals, managing labeling for multiple product variants becomes a critical task.
- July 5, 2023 Regulatory Affairs, Regulatory Software & Services
In today's highly regulated business landscape, organizations face the formidable challenge of managing an ever-growing volume of documents to ensure Regulatory compliance with diverse standards and regulations. To navigate through complexities such as document overload, compliance costs, increased audit scrutiny, etc., many businesses are adopting Regulatory Document Management Systems (RDMS).
- June 30, 2023 Medical Devices
Validation protocol is defined as a documented plan for testing a medical device to confirm that the production process used to manufacture the product meets the specific user, technical, and Regulatory requirements. This includes a review of process variables and operational limitations and the analysis of test results under actual use conditions.
- June 30, 2023 Publishing & Submissions, Regulatory Software & Services
The regulatory writing and publishing segment claimed a dominant 36.6% revenue share in 2022 (GVR report), propelled by outsourcing in the biopharmaceutical and medical device industries. Staying ahead in the fast-paced world of regulatory submissions is paramount. Embracing game-changing technologies and keeping updated yields faster approvals, fewer errors, and heightened Regulatory compliance.
- June 28, 2023 Medical Devices
Post-market surveillance (PMS) is a system through which surveillance of adverse events and malfunctions of health products in the post-market phase are carried out, aimed at recommending the adoption of measures to ensure the protection and promotion of public health.
- June 28, 2023 Medical Devices
Who is an IAA?
An Indian Authorized Agent (IAA) is a person, firm, or organization who has been appointed by an overseas manufacturer through a power of attorney to undertake the import of medical devices in India. The IAA collaborates extensively with manufacturers to understand their products and Regulatory needs and assist them in navigating the complex Indian Regulatory landscape.
- June 23, 2023 Pharmaceuticals, Regulatory Artwork Services, Regulatory Software & Services
Did you know that labeling and artwork errors are responsible for almost half of all product recalls in the pharmaceutical industry? This alarming statistic highlights the significant impact that these errors can have on the pharmaceutical supply chain. Healthcare professionals, pharmaceutical manufacturers, and regulatory bodies must address this issue proactively.
- June 22, 2023 Pharmaceuticals, Regulatory Affairs
There has been a growing trend of Rx-to-OTC switch, whereby prescription drugs/prescription-only (Rx) medicines get converted to Over-the-Counter (OTC) products. The process has gained significant attention in the pharmaceutical industry, as it has led to a potential increase in patients’ access to effective treatments while at the same time reducing healthcare costs.
- June 21, 2023 Pharmaceuticals, Regulatory Affairs, Regulatory Labeling
The annotated labeling document is a Regulatory requirement that needs to be submitted along with New Drug Applications (NDAs)/Abbreviated New Drug Applications (ANDAs)/new Marketing Authorization Applications (MAAs). This blog will give you an overview of the requirements for developing an annotated labeling package.