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 Manufacturing Record (BMR) Review

We review pre-production batch records to ensure they capture critical details for successful and reproducible manufacturing. We also review executed Batch Manufacturing Records and liaise with your QA department to inform them of any red flags and issues that need 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 subtance.

Quality Documentation Review

Careful review of development and manufacturing reports, raw data, stability data, and analytical data is a critical activity, allowing errors to be captured with greater certainty.

Disclaimer: This is not a QA role, but a CMC oversight role we assume here.

Intranasal & Inhalation Drug Development

CMC development support services for intranasal and inhalation drug-device combination products.