In the pharmaceutical industry, adhering to Chemistry, Manufacturing, and Controls (CMC) requirements is paramount for ensuring the safety and efficacy of drugs. However, Regulatory agencies often identify gaps or deficiencies in the CMC data submitted by companies, which necessitates remediation.
- July 26, 2023 Regulatory Contract Staffing, Pharmaceuticals, Regulatory Affairs
- July 26, 2023 Regulatory Contract Staffing, Pharmaceuticals, Regulatory Affairs
In the rapidly evolving landscape of Regulatory affairs, pharmaceutical and life sciences companies often require specialized expertise to navigate complex Regulatory requirements and ensure compliance. Engaging a Regulatory staff augmentation partner can be a strategic solution for meeting these needs!
- July 25, 2023 Chemicals, Consumer Healthcare, Regulatory Affairs
The European Union (EU) has implemented strict regulations to ensure biocidal products’ safe and effective use. Biocides are crucial in controlling harmful organisms such as bacteria, viruses, and pests and are widely used in various sectors, including healthcare, agriculture, and household products. Compliance with EU Biocidal Product Regulation (BPR) ensures market access and consumer protection.
- July 25, 2023 Medical Devices
Radiation-emitting product labeling applies to all products that produce sonic, infrasonic, or ultrasonic radiation. This labeling regulation is applicable in conjunction with general labeling requirements. These regulations cover only the parts of specifications that is related to product labeling. It does not address any of the standards' technical requirements.
- July 25, 2023 Medical Devices
In today’s globalized world, cultural and linguistic diversity has become increasingly important, particularly in the healthcare industry. When it comes to medical devices, artwork and visual communication play a crucial role in effectively conveying information to users. However, cultural and linguistic variations can significantly impact the understanding, acceptance, and safe use of medical devices.
- July 25, 2023 Medical Devices
The US Food and Drug Administration (USFDA) has proposed the harmonization of the 21 Code of Federal Regulations (CFR) Part 820 Quality System Regulation (QSR) for medical devices in accordance with the International Organization for Standardization (ISO) 13485:2016.
- July 25, 2023 Medical Devices
Instructions for Use (IFUs) for medical devices are documents that provide essential information and instructions on how to use the devices safely and effectively. They are typically supplied by the manufacturer and form an integral part of the device’s Regulatory requirements.
- July 24, 2023 Medical Devices
With the growing complexity and sophistication of medical device software, the Regulatory requirements for their registration are becoming increasingly stringent. In 2022, the National Medical Products Administration (NMPA), China introduced revised guidelines specifically addressing the registration process for medical device software.
- July 24, 2023 Medical Devices
As digital health startups continue to disrupt traditional healthcare practices, businesses must be compliant with regulations to ensure sustainable success. However, achieving Regulatory compliance can be a complex and arduous task. Thus, startups must adopt suitable strategies that will help them navigate the ever-changing Regulatory landscape.
- July 24, 2023 Medical Devices, Regulatory Affairs
A Quality Management System (QMS) refers to a set of systems and processes that a company adopts to ensure the quality of its products and services.