The Ministry of Food and Drug Safety (MFDS), South Korea has come up with a new revision to the rules on functional food labeling to prevent deceptive display/advertising.
- August 9, 2023 Food and Food Supplements, Regulatory Affairs, Regulatory Labeling
- August 8, 2023 Medical Devices
Brazil, the largest economy in Latin America (LATAM), is also the most promising medical device market in the region. The medical device market in Brazil is governed by the Agência Nacional de Vigilância Sanitária (ANVISA), or the Brazilian Health Regulatory Agency, which came up with a new resolution titled RDC 751, effective from March 01, 2023.
- August 8, 2023 Pharmaceuticals, Regulatory Medical Writing
Staying compliant with regulations is essential, and it is becoming increasingly difficult for organizations as Regulatory expectations continue to evolve and are sometimes specific to Regulatory Medical Writing or particular programs.
- August 8, 2023 Pharmaceuticals, Regulatory Affairs, Regulatory Medical Writing
In the rapidly evolving fields of clinical research and Regulatory Affairs, the integration of advanced technologies is crucial for improving efficacy and safety documentation in Clinical Study Reports (CSR). Quantitative Structure-Activity Relationship (QSAR) is one of the leading technologies in CSR generation and processing. Global life sciences companies have implemented QSAR for its efficacy and usability.
- August 8, 2023 Publishing & Submissions, Regulatory Software & Services
The Electronic Common Technical Document (eCTD) has become the golden standard for drug regulatory submissions worldwide, and with the advent of eCTD 4.0 in 2022, a new chapter of innovation began. While this latest version boasts remarkable benefits like heightened efficiency and precision, it also ushers in unique challenges for countries transitioning to this cutting-edge format.
- August 2, 2023 Pharmaceuticals, Regulatory Medical Writing
Health-based Exposure Limits (HBEL), also referred to as Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) values, are used to calculate Maximum Allowable Carryover (MAC/MACO) or Maximum Safe Carryover (MSC) limits in pharmaceutical cleaning validation.
- August 1, 2023 Medical Devices, Regulatory Affairs
Introduction
In a dynamic and fiercely competitive business landscape, preserving your brand identity is paramount for long-term success. A powerful tool for safeguarding your brand is “trademark registration.” By delving into the essence of trademarks and understanding their significance, we recognize their indispensable role for businesses operating in Nigeria.
- July 27, 2023 Regulatory Software & Services
In today's rapidly evolving business landscape, organizations across life science industries face stringent Regulatory requirements. Compliance with these regulations is not only crucial for legal and ethical reasons but transforming end-to-end operations with a unified RIMS suite.
- July 26, 2023 Regulatory Contract Staffing, Pharmaceuticals, Regulatory Affairs
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
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!