Analytical Reverse Engineering of Complex Formulations

At Nomisma Healthcare, we specialize in comprehensive analytical reverse engineering services for complex pharmaceutical formulations, including innovator drugs, biosimilars, peptides, proteins, and highly potent APIs. Our state-of-the-art laboratory and expert team deliver precise, defensible data to support product development, patent litigation, regulatory submissions, and FDA/EMA query responses.

Our Advanced Analytical Capabilities

We employ a full suite of cutting-edge techniques to fully characterize your reference product and establish Q1/Q2 sameness, structural elucidation, and physicochemical equivalence:

• Spectroscopic Techniques 1D & 2D NMR (structure confirmation, impurity profiling) FT-IR and Raman Spectroscopy
• Mass Spectrometry High-Resolution Mass Spectrometry (HRMS) LC-MS/MS, GC-MS, MALDI-TOF
• Chromatographic & Size-Based Analysis Gel Permeation Chromatography (GPC/SEC) HPLC, UPLC, IC methods for excipient quantification
• Thermal & Elemental Analysis Differential Scanning Calorimetry (DSC) Thermogravimetric Analysis (TGA) CHNS/O Elemental Analysis (CHN)
• Structural & Morphological Characterization X-Ray Diffraction (XRD) & Small-Angle X-ray Scattering (SAXS) Scanning Electron Microscopy (SEM) with EDX Particle size, morphology, and polymorphism studies Specific Optical Rotation (SOR)
• Peptide & Protein Characterization Full peptide sequencing (Edman degradation + MS) Primary, secondary, tertiary, and quaternary structure elucidation Disulfide bridge mapping Post-translational modification analysis
• Drug-Excipient Interaction & Compatibility Studies Excipient identification and quantitative profiling Q1/Q2 sameness demonstration for 505(b)(2), ANDA, and biosimilar submissions Comprehensive impurity and degradation pathway mapping