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 23, 2023 Pharmaceuticals, Regulatory Artwork Services, Regulatory Software & Services
- 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.
- June 20, 2023 Pharmaceuticals, Regulatory Affairs, Publishing & Submissions
In the rapidly evolving field of pharmaceutical development, time is of the essence. The ability to expedite the Regulatory approval process is crucial for meeting the urgent needs of patients, addressing unmet medical conditions, and maintaining a competitive edge in the market.
- June 20, 2023 Pharmaceuticals, Regulatory Affairs
The European Regulatory landscape presents a myriad of challenges and opportunities for pharmaceutical companies seeking to bring their products to the market. Navigating the complexities of the diverse Regulatory frameworks of the region, the varied linguistic requirements, and the ever-evolving guidelines requires a well-executed staffing strategy.
- June 20, 2023 Medical Devices
The reprocessing of Single-use Medical Devices (SUDs) has gained significant attention in recent years due to its potential cost-saving benefits and environmental impact reduction. Reprocessing involves the cleaning, sterilization, and refurbishment of certain medical devices for multiple uses, allowing healthcare facilities to save costs without compromising on patient safety.
- June 20, 2023 Medical Devices
Software as a Medical Device (SaMD) is a burgeoning field that offers innovative solutions to enhance patient care and reduce healthcare costs. The International Medical Device Regulators Forum (IMDRF) describes SaMD as a software tool intended for use in one or more medical purposes, and which meet these purposes without being part of a hardware medical device.
- June 20, 2023 Medical Devices
A combination product is a therapeutic or diagnostic product that combines drugs, medical devices, and/or biological products. It combines at least two (02) of these product categories and sometimes even combines all three (03) categories. One of the key growth drivers for this market is the increasing prevalence of chronic diseases such as diabetes, cancer, and cardiovascular diseases.
- June 20, 2023 Pharmaceuticals, Compliance, Audit and Validation, Regulatory Affairs
Regulatory inspections are crucial for ensuring compliance and quality in the pharmaceutical industry. Adequate preparation can significantly improve the efficiency and effectiveness of the process. Pharmaceutical companies must streamline their inspection process, demonstrate their commitment to compliance, and maintain a positive relationship with the Regulatory authorities.
- June 20, 2023 Medical Devices, Regulatory Affairs
As technology continues to revolutionize the healthcare industry, software applications play an increasingly critical role in the medical device industry. In Japan, the regulations surrounding Software as a Medical Device (SaMD) are robust and are specifically designed to ensure patient safety and product efficacy.