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Milestone Pharma
A Pharmaceutical Quality Research CROSubmission-ready analytical, impurity, and CMC quality solutions built for global filings.
Our Services and Solutions
We help pharma and biotech teams de-risk development with regulatory-aligned analytical and quality research. Our scientists deliver submission-ready data packages from method development and validation to impurity and nitrosamine/NDSRI studies, large molecule characterization (non-bioanalytical), E&L/CCIT, and reference standards across the full product lifecycle.
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Nitrosamine & NDSRI Services
End-to-end support from risk assessment and method development to confirmatory testing and reporting.
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In Vitro Bioequivalence
Regulatory-aligned in vitro models across dosage forms to support formulation development and BE strategy.
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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.
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Analytical Method Development & Validation
Fit-for-purpose methods (HPLC/UPLC/GC and more) with validation documentation to support IND/NDA submissions.
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Pharmaceutical & Medical Device Testing (E&L, Sterility, Biocompatibility)
Data to support container-closure safety and integrity, guided by QbD and PQRI best practices.
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Nanoparticle Characterization
Physicochemical characterization to understand critical quality attributes and support comparability.
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Reference Standards & Impurity Synthesis
Custom synthesis, isolation/purification, and structure elucidation to accelerate CMC timelines.
About 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.
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10 + 10 +Years of Experience
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290 + 290 +Scientists & Engineers
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2,500 + 2,500 +Global Customers
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10,000 + 10,000 +Projects Delivered
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9,800 + m² 9,800 + m²Independent Laboratories
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40% + 40% +MSc/PhD Ratio
Why Choose Us
A quality research CRO built for global filings. Here’s what you get when you partner with us:
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Submission-ready, regulator-aligned deliverables
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Audit-ready quality systems and data integrity
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End-to-end quality research across the product lifecycle
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Specialized expertise for complex modalities and high-risk impurities
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A responsive partnership built around your milestones
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Data packages and reports aligned with FDA/EMA/NMPA expectations
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QA-reviewed documentation, traceability, and inspection support
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From early development through post-approval changes
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Advanced capabilities including nitrosamines/NDSRIs, E&L/CCIT, and reference standards
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Right-sized scopes, fast iteration, and a single point of contact
Core Differentiators
Milestone Pharma is a pharmaceutical quality research CRO helping global teams build robust CMC and analytical strategies. We deliver high integrity, regulatory aligned data packages to support development, IND/NDA submissions, and post approval changes.
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Regulatory-aligned approach designed for FDA, EMA, NMPA, and other global expectations
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End-to-end analytical, impurity, and CMC quality solutions across the product lifecycle
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Submission-ready reports, method packages, and documentation to support global filings and inspections
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Integrated expertise across key platforms: nitrosamine/NDSRI, IVBE, E&L/CCIT, nanoparticles, and reference standards
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Mar 09, 2026USP High Level Delegation Visits Milestone Pharma for In Depth Strategic Exchange
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Dec 04, 2025Milestone Pharma Successfully Passes EU QP On Site Audit, Achieving Another Milestone in Regulatory Compliance
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Dec 14, 2023Milestone Pharma Shanghai Facility Successfully Passes US FDA On Site Inspection with Zero Observations
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Aug 08, 2023Milestone Pharma Nanjing Facility Successfully Passes US FDA On Site cGMP Inspection
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