Stability Studies & Shelf-Life Assurance

• ICH-Compliant Stability Programs: Design and execute stability studies (accelerated, real-time, and photostability) to determine shelf life, storage conditions, and expiration dates. We align with ICH Q1A-Q2B guidelines, ensuring global submission readiness.

• Data Analysis & Trending: Use advanced statistical tools to predict degradation trends, identify outliers, and justify shelf-life extensions.

• Stress Testing & Forced Degradation: Uncover hidden product vulnerabilities under extreme conditions to refine formulations and packaging.

Environmental Monitoring (EM) & Contamination Control

• EM Program Design: Build risk-based environmental monitoring programs for aseptic facilities, cleanrooms, and critical zones. We focus on viable/non-viable particle monitoring, air quality, and surface sampling.

• Contamination Control Strategy: Mitigate risks with science-driven approaches:

  • Risk Assessments: Identify contamination hotspots using FMEA and Quality Risk Management (QRM).

  • Cleaning Validation: Develop protocols to prevent cross-contamination in multi-product facilities.

  • Microbial Control: Implement rapid microbial methods (RMM) and biocontamination action plans.

Tech Transfer & Method Validation

• Analytical Method Transfer: Ensure seamless transfer of QC methods between labs, sites, or CDMOs. We handle protocol development, equivalence testing, and troubleshooting to avoid “method drift.”

• Method Validation/Verification: Full ICH Q2(R1)/USP validation for HPLC, GC, dissolution, and microbiological assays. We ensure reproducibility, precision, and robustness.

Reference Material Qualification & Management

• Reference Standard Qualification: Certify the identity, purity, and potency of reference materials (primary/secondary standards) in compliance with USP, EP, and ICH guidelines.

• Supplier Audits & Sourcing: Vet and qualify suppliers of reference materials to ensure traceability, proper handling, and documentation.

• Lifecycle Management: Establish protocols for storage, requalification, and retirement of reference materials to maintain integrity over time.

• Documentation & Compliance: Prepare Certificates of Analysis (CoA) and audit-ready documentation to meet FDA/EMA expectations during inspections.

Lab Compliance & Operational Excellence

Build audit-ready QC labs that balance efficiency with regulatory rigor.

• Includes: Mock FDA/EMA inspections, data integrity remediation, rapid contamination investigations, QC submission support, and digital LIMS integration.

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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