In recent times, the emergence of nitrosamine impurities in certain generic drug substances has prompted a re-evaluation of industry practices. This blog takes a deep dive into the multifaceted world of nitrosamine mitigation, specifically in the context of generic drug products. Moreover, it also throws light upon considerations made for Nitrosamine Drug Substance Related Impurities.
- November 16, 2023 Pharmaceuticals, Regulatory Affairs
- November 15, 2023 Cosmetics Regulatory Services, Regulatory Affairs
Cosmetic products are regulated so that they are safe for regular/repeated use and efficacious as claimed or presumed. Historically, cosmetics were supposed to be a blend of overtly safe ingredients with an onus of safety lying majorly with the industry.
- November 15, 2023 Cosmetics Regulatory Services, Regulatory Affairs
The Modernization of Cosmetics Regulation Act 2022 (MoCRA) represents a pivotal moment in the US FDA's authority over the cosmetics industry, marking a significant update to the regulations established in the Federal Food, Drug, and Cosmetic (FD&C) Act of 1938. Among the array of new requirements introduced by MoCRA, adverse event reporting stands out as a critical component.
- November 10, 2023 Pharmacovigilance, Regulatory Affairs
Good pharmacovigilance practices (GVP) are a set of guidelines established by regulatory authorities to ensure the safety of medicinal products. These guidelines provide a comprehensive framework for monitoring, evaluating, and reporting adverse drug reactions (ADRs). However, there are certain situations where exceptions or modifications to GVP may be necessary.
- November 10, 2023 Pharmacovigilance, Regulatory Affairs
In the ever-evolving world of pharmaceuticals, ensuring patient safety remains a paramount concern. As new drugs emerge and treatment options expand, the importance of pharmacovigilance, the science of monitoring and evaluating drug safety, has never been greater.
- November 10, 2023 Pharmaceuticals, Regulatory Affairs
Japan is a key market for the pharmaceutical industry, but its drug approval process can be complex and daunting. If you are seeking to introduce a new drug into the Japanese market, you must understand the drug approval process and navigate it effectively.
- November 8, 2023 Cosmetics Regulatory Services
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marks a historic milestone in the US FDA's oversight of cosmetics. It represents the most significant expansion of the US FDA since the inception of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938.
- November 8, 2023 Pharmaceuticals, Regulatory Artwork Services
In the pharmaceutical industry, precision, safety, and compliance are paramount, and hence the role of artwork quality checks holds a critical place. It's not just about aesthetics; it's about ensuring that every piece of artwork adheres to strict Regulatory standards and maintains the integrity of the brand.
- November 8, 2023 Pharmaceuticals, Regulatory Artwork Services
The pharmaceutical industry operates in a complex landscape where compliance with stringent regulations is paramount. One area where this is particularly crucial is in the creation and management of Regulatory artwork. Regulatory artwork encompasses everything from packaging and labeling to product inserts and documentation.
Unlocking the Potential of South Korea's Pharmaceutical Industry: An Overview of the NDA/BLA Process
November 8, 2023 PharmaceuticalsPharmaceutical businesses looking for new business prospects find South Korea to be an attractive market with a fast-increasing pharmaceutical industry. With over nine-hundred (900) new drugs in the pipeline and exports totalling USD 3.1 billion, South Korea provides enormous potential for big pharma manufacturing.