Bioanalytical Services

Analytical &

End-to-end analytical chemistry solutions that combine technical excellence, regulatory expertise, and scientific insight.

Analytical Chemistry & Bioanalytical Capabilities

At QIMA Life Sciences, we provide end-to-end analytical chemistry solutions that combine technical excellence, regulatory expertise, and scientific insight. From early-stage development to regulatory compliance, our services cover the entire spectrum of chemical and bioanalytical challenges. Our mission is to deliver reliable, meaningful analytical data to support formulation development, product safety, and regulatory compliance across the pharmaceutical, cosmetic, nutraceutical, veterinary, and medical device sectors.

Core expertise

  • Stability & Shelf-Life Studies
    Method development, forced degradation studies, and real-time stability programs (RDC 964/2025, RDC 318/19) under controlled climatic zones.

  • Impurity & Degradation Product Management
    Identification and structural elucidation of impurities and degradation products; synthesis and characterization of reference standards; quantification of residual solvents and metallic impurities (RDC 166/2017).

  • Nitrosamines & Risk Assessment
    Advanced analytical solutions for nitrosamine detection and quantification, risk assessment, and nitrosating agent identification in active ingredients, excipients, and final products.
    We develop custom LC-MS/MS and GC-MS methods to meet EMA/FDA/ANVISA requirements and support root cause analysis or preventive quality strategies.

  • Analytical Method Development & Validation
    Tailored LC, GC, and MS method design and validation (ICH, USP) for dissolution, solubility, permeability, process validation, and QC testing.

  • Extractables & Leachables (E&L)
    Comprehensive characterization of materials and packaging for medical devices and combination products, including toxicological risk assessment and AET calculations.

  • Advanced Analytical Applications
    Peptide and nutraceutical profiling, metabolomics, lipidomics, and biomarker identification for efficacy and mechanism-of-action studies.

Instrumentation & Technologies

We deploy a comprehensive suite of advanced analytical tools including:

  • Liquid Chromatography (LC / UHPLC / UPLC) with detectors such as UV, Fluorescence, Charged Aerosol Detector (CAD), MS/MS.

  • Gas Chromatography (GC / GC-MS) for volatile, semi-volatile compounds, residual solvents, extractables & leachables.

  • Mass Spectrometry (MS / HRMS / Triple Quadrupole / Orbitrap / Q-TOF) for high-sensitivity quantification, structural elucidation, untargeted & targeted analyses.

  • Spectroscopy & Structural Analysis: NMR, FTIR, UV-Vis, Atomic Absorption / Emission, XRD, etc.

  • Thermal Analysis: DSC, TGA, and others for characterizing physical-chemical stability.

Matrices

We handle a wide variety of sample types, including:

  • Natural extracts, active ingredients, and raw materials

  • Pharmaceutical / cosmetic formulations (solids, semi-solids, liquids)

  • Biological matrices: plasma, serum, urine, bile, soft tissues (liver, brain, muscle), sweat, sebum, etc.

  • Non-invasive / specialized sampling (skin biopsies, explants, reconstructed tissues)

Quality & Compliance

  • Operations under GLP / GMP / REBLAS (ANVISA)
  • Full instrument qualification, calibration, and proficiency testing (Controllab)
  • Compliance with ICH, USP, EMA, and FDA analytical validation guidelines
  • Robust data integrity and traceability systems ensuring defensible results
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