Next Level Impurity Profiling

Any lab can record an HPLC or an LCMS. Few do it exquisitely. We collaborate with state-of-the-art labs for impurity/degradation product profiling (LCMS/MS) and structure elucidation.

Potential Genotoxic Impurity (PGI)

In-depth investigation of manufacturing processes to identify PGIs.

Assistance with establishing analytical methods to monitor PGIs.

Review of 1D and 2D NMR peak assignments

Are your Drug Substance NMR spectra correctly interpreted? We review 1D and 2D 1H, 13C, 15N COSY, NOESY, HSQC, and HMBC NMR spectral assignments to ensure correct structure elucidation.

Materials Characterization

Particle size distribution, plume geometry, 1D/2DNMR, FTIR, mass spectrometry, DSC, XRPD, DVS, chiral HPLC, powder flowability. Which techniques and analyses are required for your Drug Substance and Drug Product?

Batch Record Review

We review pre‑production batch records to ensure they capture all critical details required for successful and reproducible manufacturing.

We also assess executed Batch Manufacturing Records and coordinate with your QA department to highlight any red flags or issues that require resolution.

Regulatory Starting Material Evaluation

Health authorities are increasingly challenging regulatory starting material nomination, even for early phases of development.

We provide guidance to RSM nomination based on a Risk Assessment of the manufacturing process for starting materials and drug substance.

Quality Documentation Review

A rigorous review of development and manufacturing documentation— including technical reports, raw data, stability results, and analytical data sets— is essential to ensuring accuracy, consistency, and scientific integrity. Our oversight helps identify discrepancies and potential issues early, strengthening the reliability of your CMC package.

Note: This service is provided as part of our CMC oversight function and is not a substitute for formal QA review.

Intranasal & Inhalation Drug Development

CMC‑Rx Consultancy can provide specialized support for intranasal and inhalation drug–device combination products, addressing the unique technical and regulatory considerations associated with these delivery systems. Our services include support for formulation and device compatibility, device selection, drug-device integration and CMC Strategy, vendor and CDMO oversight, analytical and performance testing, risk assessment and trouble shooting.