Method Development & Validation

• ICH-Compliant Methods: We develop HPLC, GC, and dissolution methods optimized for your drug’s unique profile. Every method is validated for precision, accuracy, and robustness.

• Method Transfer: Avoid “lab-to-lab” variability. We ensure seamless method transfers between R&D, CMOs, and QC labs, with full documentation.

Analytical Testing

• Stability Studies: Predict shelf life with confidence. Our accelerated and real-time stability studies comply with ICH Q1A-Q1E guidelines.

• Raw Material & Release Testing: Fast, accurate testing services that keep your supply chain moving.

Data & Regulatory Strategy

• Statistical Analysis: Turn data into decisions. Our statisticians analyze trends, validate processes, and prepare submission-ready reports.

• Regulatory Submissions: We draft analytical sections for FDA/EMA dossiers, ensuring your data meets CTD format and reviewer expectations.

Training & Innovation

• Analytical Upskilling: From HPLC troubleshooting to AI-driven data analysis, we train your team in the latest techniques.

Why Molgenium?

More Than Consultants—We’re Your Strategic Partners

• Global Expertise, Local Insight: Our team includes ex-regulators, seasoned QPs, and Six Sigma Black Belts who speak the language of compliance and innovation.

• Tailored Solutions: No cookie-cutter approaches. We adapt to your unique needs, whether you’re a startup or a global enterprise.

• End-to-End Support: From audit to approval, we’re with you at every milestone.

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