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Why Choose Milestone Pharma？

Milestone Pharma supports global pharma and biotech teams with pharmaceutical quality research across analytical development, impurity and nitrosamine/NDSRI studies, E&L/CCIT, and reference standards. Our focus is simple: deliver reliable, regulatory-aligned data you can use for decisions and filings.

Services

  • Submission-ready, regulator-aligned deliverables

    Data packages and reports aligned with FDA/EMA/NMPA expectations

  • Audit-ready quality systems and data integrity

    QA-reviewed documentation, traceability, and inspection support

  • End-to-End quality research across the product lifecycle

    From early development through post-approval changes

  • Specialized expertise for complex modalities and high-risk impurities

    Advanced capabilities including nitrosamines/NDSRIs, E&L/CCIT, and reference standards

  • A responsive partnership built around your milestones

    Right-sized scopes, fast iteration, and a single point of contact

Uncompromising Data Integrity

Security Controls and Electronic Data Management

  • Security & Access Control

    • Role-based permissions and unique user IDs

    • Password complexity and expiry rules

    • USB disabled; time/time-zone lock; screen-lock settings

  • Electronic Data Management

    • Integrated digital systems (DMS, ELN, CDS) with role-based control

    • Controlled data storage (paths, naming rules, access rights)

    • Automatic backup with routine verification

    • Web-based systems with audit trail enabled

Robust Quality Assurance System

Accredited laboratories and cGMP quality framework

  • 01

    Accreditation & Compliance

    CNAS-accredited laboratory system (ISO/IEC 17025)

    cGMP mindset and QA oversight across studies

    Successfully passed FDA inspections, EU-QP audits and multiple NMPA inspections

    Audit support for clients and partners

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  • 02

    Quality Governance

    Independent QA oversight and document control

    Deviation/OOS investigation support (as applicable)

    Training, change control, and continuous improvement

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  • 03

    Built to Serve Global Programs

    Our QA and data systems are designed to support submission-ready deliverables and inspection readiness—helping clients reduce audit friction across regions.

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Laboratory Facilities and Equipment

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What Clients Typically Use Us For?

  • Reference Standards & Impurity Synthesis

    • Custom synthesis, isolation/purification, and structure elucidation to accelerate CMC timelines.

  • Nanoparticle Characterization

    • Physicochemical characterization to understand critical quality attributes and support comparability.

  • Extractables & Leachables (E&L) and CCIT

    • Data to support container-closure safety and integrity, guided by QbD and PQRI best practices.

  • Analytical Method Development & Validation

    • Fit-for-purpose methods (HPLC/UPLC/GC and more) with validation documentation to support IND/NDA submissions.

  • Large Molecule Characterization

    • Characterization of primary structure, higher-order structure (secondary/tertiary), impurity profiling, and aggregation/particle profiles to support CMC development, comparability, and regulatory submissions.

  • In Vitro Bioequivalence

    • Regulatory-aligned in vitro models across dosage forms to support formulation development and BE strategy.

  • Nitrosamine & NDSRI Services

    • End-to-end support from risk assessment and method development to confirmatory testing and reporting.

Discuss My Project

Speak with an expert about your upcoming project to see how we can help you.

Contact Us