Explore our range of services focused on excellence in research and development and laboratory operations.

Biowaiver Applications

🔹Regulatory-compliant in vitro studies supporting biowaiver applications in accordance with EMA guidelines
🔹 Accurate bioavailability (BA) and bioequivalence (BE) predictions
🔹 Tailored Design of Experiment (DoE) protocols to optimize study efficiency
🔹 (U)HPLC-PDA-based dissolution profiling for precise drug release characterization
🔹 Phoenix RDS diffusion testing for advanced permeability assessments
🔹 Comprehensive data evaluation using Lean Six Sigma principles
🔹 Robust in vitro-in vivo correlation (IVIVC) models for enhanced regulatory confidence

🚀 Accelerate your biowaiver applications with our services

CMC Regulatory Compliance

 

🔹 Preparation of Module 3 submission documents, 

🔹 Comprehensive risk assessments for elemental impurities, extractables and leachables, and nitrosamine impurities
🔹 Advanced impurity identification using LC-MS and NMR, in collaboration with leading research institutions
🔹 Reaction kinetic calculations to predict product shelf life across different regions and climate zones
🔹 Regulatory support for new market authorization applications

🔹Change Control Management

🚀 We ensure your regulatory success!

 

 

Cleaning Validation

🔹Regulatory Compliance

🔹Ensures adherence to FDA, EMA, and cGMP standards.

🔹Reduces regulatory risks and enhances audit readiness.

🔹Residue Limit Setting

🔹Establishes safe carryover limits using toxicological and pharmacological assessments.

🔹Ensures patient safety and compliance with industry standards.

🔹Study Design

🔹Evaluates worst-case scenarios for cleaning validation.

🔹Implements effective sampling methods (swab, rinse sampling).

🔹Analytical Method Development & Validation

🔹Develops sensitive and specific analytical methods.

🔹Ensures accuracy, precision, and compliance with ICH Q2 R1 guidelines.

🔹Documentation & Ongoing Monitoring

🔹Provides validation protocols, reports, and SOPs.

🔹Supports continuous monitoring and periodic revalidation.

🚀 Ensure product safety with our cleaning validation program!

Pharmaceutical Manufacturing & Technology Transfer Consulting

 

  • 🔹 Drug Product Scale-Up & Technology Transfer for seamless transitions to commercial production
    🔹 Regulatory Compliance, Quality Assurance & Change Control Management to meet global standards
    🔹 Analytical Support & Process Optimization to enhance manufacturing efficiency
    🔹 Risk Management & Operational Excellence using Prince2 Project Management and Lean Six Sigma methodologies
    🔹 Quality by Design (QbD) Process Improvement for robust and efficient drug development

    🚀 Drive efficiency and compliance with our expertise!

 

 

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