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Analytical Method Development & Validation

Milestone Pharma Laboratory provides end-to-end method development, method transfer, and validation services. Equipped with multiple models of high-sensitivity instruments and the latest software systems, we fully support your analytical workflow to ensure methods are robust and compliant with global regulatory requirements at every stage, covering all phases from preclinical through commercialization and beyond.

Overview

At Milestone Pharma, we integrate early-stage analytical method development and validation to minimize risk and accelerate drug development.

Our phase-appropriate solutions cover method design, qualification, validation, and transfer, ensuring robust performance from preclinical to commercialization. Leveraging advanced chromatographic, spectroscopic, and physicochemical techniques, we support small molecules, biologics, and complex formulations. Full compliance with ICH Q2, NMPA, FDA, and EMA guidelines, guarantees reliable data for drug substance and product quality, safety, and efficacy. Partner with us for customized, science-driven analytical strategies.


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Services

Method Development and Validation Suitability for Chemistry/Biochemistry

  • API

    • Assay/Potency, Purity/Impurity 

    • Residual solvents 

    • Mutagenic/structural alert/PGIs/Nitrosamine impurity 

    • Trace Metals 

    • Physicochemical characterization 

    • Identity confirmation (IR, NMR or MS) 

    • qNMR quantitative assay or ID test

  • Finish Product

    • Assay/degradation product methods (HPLC; phase-appropriate approach)

    • Stability-indicating methods (forced degradation based)

    • Blend uniformity, content uniformity & assay

    • Dissolution methods: QC method to biorelevant media

    • Determine disintegration vs. dissolution as control test

    • Biorelevant dissolution to support formulation screening

    • Multimedia dissolution to support regulatory submission

  • Excipients & Packaging

    • Compendial ID / assay / related substances testing

    • Water content (KF), residual solvents, elemental impurities (ICH Q3D)

    • Nitrite/nitrate and high-risk impurity monitoring when applicable

    • Packaging materials physicochemical tests (USP/EP/ChP/YBB as applicable)

    • E&L screening and compatibility support; CoA verification

    • Container closure integrity (CCIT) support for systems and components

  • Microbiology

    • Mycoplasma

    • Microbial Challenge Studies

    • Sterility - USP<71>, EP 2.6.1

    • Endotoxin - USP<85>, USP<86>, EP 2.6.14

    • Microbial Limits

    • Antimicrobial Preservative Effectiveness

    • Disinfectant Efficacy Testing

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Advanced Technologies

Successful molecule dependent methods have been developed for the following techniques:

  • Microbiology

    Endotoxin, Sterility, AET and Microbial Limit


  • Elemental Analysis

    ICP-MS, ICP-OES, AAS


  • Mass Spectrometry

    LC-MS (Orbitrap, qTOF, Triple Quad), GC-MS, (Orbitrap, Triple Quad, Single Quad)


  • Dissolution Testing

    Intrinsic, Extrinsic, UV and HPLC readout, Friability


  • Aerodynamic Performance Characterization(OINDP)

    APSD (NGI), DDU, Droplet size distribution, Spray pattern & Plume geometry


  • Solid State Characterization

    Particle size determination (PSD), Microscopy (optical, SEM, TEM), Specific surface area, X-ray diffraction (XRD, XRPD), Differential scanning calorimetry (DSC), Isothermal calorimetry, Solution calorimetry, Thermogravimetric analysis (TGA, TG-FTIR), Dynamic/Gravimetric vapor sorption (DVS/GVS),  Microscopy (optical), And water activity measurements. All methods are performed under GMP conditions to ensure quality and compliance.


  • Physicochemical

    Osmolarity, Density, Viscosity (rolling ball, capillary, rheometer) ,nDSC, Visible and subvisible particles (membrane microscopy, Light obscuration, Flow imaging)


  • Chromatography

    HPLC (IEX, SEC, RP, HIC, HILIC, NP, IC, FL, RI, ELSD, MALLS and MS detection)


  • Spectroscopy

    CD , FL, FT-IR, Raman, SEM-EDX NMR, DLS, MALLS, AUC


Featured Strengths

  • High-Sensitivity Analytical Instrumentation

    We are equipped with advanced instruments including high-resolution mass spectrometry (Q-TOF, Orbitrap), ICP-MS, GC-MS/MS, and preparative HPLC, enabling trace-level detection of genotoxic impurities (GTIs), nitrosamines, elemental impurities, and unknown degradation products at ppm to ppb levels.

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  • State-of-the-Art Software Systems

    Our laboratories operate under fully integrated, compliance-oriented software systems, including OpenLab and Chromeleon for chromatography data systems (CDS), as well as Nexus Sarah & Derek for toxicological assessment. Electronic lab notebooks (ELN) are also deployed to ensure data integrity in accordance with ALCOA+ principles.

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  • Extensive Method Library

    We maintain a proprietary library of over 1,000 validated analytical methods covering small molecule impurities, biologics critical quality attributes (CQAs), extractables and leachables (E&L), and more. This enables rapid, phase-appropriate method development and reduces client project timelines by 30–50%.

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  • Global Regulatory Audit Experience

    Milestone Pharma has successfully passed multiple CNAS accreditations, NMPA on-site inspections, FDA on-site inspections, and EU Qualified Person (QP) audit certifications. Our quality system and analytical data packages are fully compliant with cGMP, ICH, USP, EP, and 21 CFR Part 11 requirements, ensuring regulatory readiness for global IND, NDA, and BLA submissions.

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FAQ

  • Which parameters should be optimized during analytical method development to ensure validation readiness?

    To ensure the method is suitable for validation, critical quality attributes should be optimized, including instrument parameters and sample preparation procedures, while ensuring method sensitivity and specificity. Milestone Pharma adopts a science- and risk-based approach for parameter optimization to ensure robust method performance and compliance with regulatory requirements.

  • What is the analytical method lifecycle and why is lifecycle management important?

    The analytical method lifecycle refers to the end-to-end process of developing, validating, and maintaining a laboratory method to ensure it reliably measures what it is intended for. Lifecycle management involves ongoing monitoring, improvement, and control of the method and samples, ensuring continued accuracy and compliance over time. At Milestone Pharma, we integrate lifecycle principles into our method development and validation services to support phase-appropriate regulatory readiness and product quality from preclinical through commercialization.

  • What is the difference between method feasibility, method validation, and method verification?

    Method feasibility is usually performed before validation to assess whether a method is suitable for its intended purpose. Method validation confirms that a non-compendial or developed method meets predefined performance criteria. Method verification use to confirm that the method performs acceptably for a specific API, product, or matrix.

  • How do you ensure analytical methods meet global regulatory expectations?

    Analytical methods should be developed and validated according to phase-appropriate requirements and relevant guidelines, such as ICH, USP, EP, NMPA, FDA, and EMA expectations. A compliant workflow should include risk-based method design, approved protocols, controlled documentation, data integrity practices, and scientifically justified acceptance criteria.

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