Impurities Safety Evaluation
Residuals of starting materials, intermediates, and degradation products can give rise to impurities in drug substances and drug products. Establishing limits for these impurities is a crucial aspect of pharmaceutical development to ensure the quality and safety of the product. SAXOCON provides you with everything you need to establish and document Permitted Daily Exposure (PDE) in accordance with regulatory requirements, including:
- ICH M7 classification of mutagenic impurities using (Q)SAR and read-across methods
- Categorisation and classification of organic impurities according to ICH Q3A, Q3B, and Q3C
- Establishing PDE based on the methods and principles in ICH Q3C
- Control of elemental impurities in accordance with ICH Q3D, European and US Pharmacopoeias
Why choose us?
SAXOCON services for pharmaceutical development give you access to:
- Extensive experience with state-of-the-art safety assessments of pharmaceutical products according to international standards and regulatory guidelines
- Best-in-class experience using computer models for prediction of toxicological effects, i.e. (Q)SAR models
- Smart, cost-effective test strategies that bring your products to market in a timely manner
SAXOCON compiles all necessary documentation for your New Drug Application file to fulfil ICH Q3A, Q3B, Q3C, Q3D, and M7 requirements.
drug candidate Screening
QSAR based active substance screening.
Ensure the safety of your packaging.
Ensure your combination products compliance.