A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...
Training Course (Mar 20, 2026)" has been added to ResearchAndMarkets.com's offering. In the EU, all companies are required to provide risk management plans (RMPs) for every new ...
The main market opportunities lie in developing comprehensive training and support services for implementing and integrating clinical quality management systems (CQMS) that align with evolving ...
The market opportunity lies in providing training and tools for EU RMP compliance, focusing on creating and updating RMPs per regulatory standards. Key services include offering practical guidance on ...
ABSTRACT: For the identification of the seven Nitrosamine Impurities i.e. N-Methyl-N-Nitrosopropane-1,3-diamine (Nitroso MAPA), N-Nitrosomethyl phenylamine (NMPA), N-Nitrosoethylisopropylamine (NEIPA) ...
CITI Program updates GCP curriculum and launches new course in response to ICH E6(R3) to support clinical trial compliance and training. Our updated GCP curriculum ensures that sponsors, investigators ...
Discover a generic gas chromatography method for efficiently analyzing residual solvents in pharmaceuticals, ensuring compliance with regulatory standards. A generic gas chromatography (GC-HS) method ...
ABSTRACT: Purpose: This study aimed to evaluate the safety profile and clinical acceptance of FemPhylloTM, a novel ready-to-use base for mucoadhesive vaginal films, in the context of personalized ...
Here we explore the objectives and significance of material risk assessments, classify raw materials by risk profile, and investigate critical risk categories, including microbial contamination and ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback