Pharmaceutical Services
Drug Candidate Screening
Boost your drug discovery success rate with SAXOCON’s validated QSAR and read-across (RAX) models. We identify structural alerts and predict biological effects, providing early ICH M7 classifications. Our expert statements offer cost-effective, data-driven candidate selection to accelerate your pipeline.
Impurity Safety
Master impurity limits with SAXOCON’s expert PDE documentation. We provide ICH M7 classifications via (Q)SAR, categorize organic impurities per ICH Q3A/B/C, and control elemental impurities for ICH Q3D. Our assessments ensure your products meet all safety standards with cost-effective data.
Study Sponsor Monitor
Ensure study integrity with SAXOCON’s end-to-end GLP monitoring. We develop your strategy for FDA/EFSA by selecting high-quality CROs and acting as an expert intermediary. Our experts review conclusions and safety data, providing smart, cost-effective oversight for your final documentation.
Primary Packaging Safety
Ensure your primary packaging safety. SAXOCON provides material characterization, risk analyses, and E&L strategies that follow ICH, FDA, and EMA requirements. We use proprietary supplier data to assess results and deliver the technical documentation you need to satisfy global standards.
Drug-Device Safety
Navigate drug-device complexity with SAXOCON’s cost-effective strategies. We align your development plan with FDA and EMA requirements, providing material screening, E&L monitoring, and toxicological risk assessments. Our expert documentation and proprietary data ensure your compliance.
Nitrosamine Impurities
Ensure EMA and FDA nitrosamine compliance with SAXOCON. We deliver EMA/409815/2020 compliant Step 1 risk evaluations and expert (Q)SAR analyses. Plus, we monitor studies, manage supply chain risks, and deliver toxicological reports that secure global market access.
Unexpected Findings
Resolve particulate matter findings quickly with SAXOCON’s 2–3 week SLA. We identify root causes, offer expert sampling guidance, and deliver toxicological risk assessments to support release or recall decisions. Our multidisciplinary team ensures GMP compliance and product safety with data you can trust.
Equipment Safety
Ensure production line safety with SAXOCON. We deliver material characterization, risk analysis, and extractables testing strategies aligned with USP & EP standards. Our experts leverage proprietary supplier data for toxicological assessments, providing the GMP documentation required for compliance.
Manufacturing Change Control
Don’t let change slow you down. Maintain your GMP and control the impact of changes, deviations, or non-conformities. SAXOCON’s expert evaluations ensure you stay compliant with ICH Q7, Q8, and Q9 requirements while changing your manufacturing processes.
Cleaning Validation
Prevent cross-contamination and costly audit failures with SAXOCON’s expert cleaning validation. Our advanced (Q)SAR methods establish precise PDE levels that satisfy strict EMA requirements for shared manufacturing facilities. Secure production integrity and minimise downtime with our services.
Technically Unavoidable Particles
Don’t let mystery particles halt production. Manage Technically Unavoidable Particles (TUPs) proactively with a TUP Profile (TUPP). SAXOCON identifies foreign matter early, providing the data you need to mitigate risk, protect safety, and ensure total regulatory compliance.
ICH M7 Assessments
Time is not your friend. Impurities can emerge during chemical synthesis or degradation during manufacturing and storage. SAXOCON provides fully ICH M7-compliant assessments of mutagenic potential using (Q)SAR and expert review. Secure your product safety and ensure regulatory compliance.