The General Data Protection Regulation (GDPR) is a comprehensive privacy law enacted in the European Union in 2018. It applies to all organizations that process the personal data of individuals located in the EU, regardless of where the organization is located.
- August 25, 2023 Medical Devices, Regulatory Affairs
- August 25, 2023 Medical Devices, Regulatory Affairs
The Health Sciences Authority (HSA) is Singapore's Regulatory agency in the sphere of healthcare products.
- August 25, 2023 Medical Devices
When it comes to gaining Regulatory approval for medical devices, manufacturers must navigate a complex and time-consuming pathway. However, there is a powerful method at their disposal – the pre-Request for Designation (pre-RFD) submission. The pre-RFD submission allows manufacturers to seek early feedback from the United States Food and Drug Administration (US FDA) prior to embarking on the official Regulatory process.…
- August 24, 2023 Pharmaceuticals, Compliance, Audit and Validation
In the dynamic business world, maintaining compliance, mitigating risks, and optimizing processes are critical for ensuring sustainable growth. As your organization navigates the complexities of the modern marketplace, a powerful tool that can bolster your efforts is an audit management system.
- August 22, 2023 Pharmaceuticals, Compliance, Audit and Validation
In the world of Pharmaceuticals, ensuring the safety, efficacy, and quality of drugs is essential. To achieve this, pharmaceutical companies must adhere to strict regulations and guidelines set by Regulatory authorities. Change control is a key aspect of maintaining compliance and ensuring the integrity of pharmaceutical products.
- August 22, 2023 Regulatory Affairs, Regulatory Software & Services
In today's world, businesses in regulated industries like healthcare and life sciences need to follow compliance with industry-specific regulations. Regulatory documents serve as vital communication tools with governing authorities, demonstrating adherence to guidelines, ensuring public safety, and supporting critical business decisions.
- August 21, 2023 Pharmaceuticals, Medical Devices
Innovations in drug-device combinations have led to significant advancements in patient care. Drug product(s) coupled with medical devices offer targeted drug delivery, improved therapeutic outcomes, and enhanced patient adherence. However, navigating the Regulatory landscape for drug-device combinations can be complex.
- August 16, 2023 Pharmaceuticals, Regulatory Affairs
In the highly regulated landscape of the Life Sciences industry, adhering to Product-specific Guidelines (PSGs) is paramount for successful drug development and approval. PSGs are comprehensive documents issued by global Health Authorities (HAs) to provide guidance for pharmaceutical product approvals within specific therapeutic categories.
- August 11, 2023 Regulatory Contract Staffing, Pharmaceuticals, Regulatory Affairs
Emerging pharmaceutical markets, including countries such as Brazil, India, China, South Africa, and Mexico, are experiencing remarkable growth and transformation fuelled by advancements in healthcare and increasing access to medicines.
- August 9, 2023 Food and Food Supplements, Regulatory Affairs
Indonesia has taken a step ahead in regulating processed foods and beverages. A set of guidelines or biotic regulations has been rolled out by the Badan Pengawas Obat dan Makanan (BPOM), or the Agency for Food and Drug Control/Indonesian Food and Drug Authority.