Expertise: Consulting 225 results
Analytical Target Profile The analytical target profile (ATP) concept was first introduced in the ICH Q141 Guideline in 2022. This guideline, which compliments the ICH Q22 Guideline, describes science and risk-based approaches for developing and maintaining analytical procedures suitable for...
In 2022, ICH Q14 officially introduced the enhanced approach1 in analytical development as an alternative path to the minimal approach, the benefits of which are worth exploring further. Analytical data is essential in demonstrating the safety and quality of pharmaceutical...
I recently had the opportunity to participate in the 2024 Drug Information Association (DIA) Regulatory Submissions, Information and Document Management (RSIDM) Forum held in North Bethesda, Maryland. In this blog post, I'll share my insights and key takeaways from the...
Adherence to cGMP regulations assures the identity, potency, purity and quality of biologics or advanced therapeutics and helps ensure adequate control of manufacturing operations. A primary way to demonstrate these attributes for a biologic product under development is through assays....
The FDA's January 2020 guidance, Chemistry, Manufacturing and Control (CMC)[1] Information for Human Gene Therapy Investigational New Drug Applications (INDs), outlines the analytical methods that define the quality, safety and efficacy of gene therapy therapeutics. The analytical package, consisting of...
CE marking provides access to a market of over 500 million consumers across all 27 member states of the European Union (EU), as well as Iceland, Norway, and Liechtenstein. For medical devices and in vitro diagnostics (IVDs), a CE mark...