Analytical Development

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Medicilon provides full range of analytical services, including method development and validation, analytical testing and release, stability study, large scale separation and regulatory CMC documentation services. State-of-the-art instruments, cutting-edge technologies and experienced scientific staff ensure efficient, high-quality and cost-effective services.

Analytical/Stability/CMC Package for IND/CTA, NDA/MAA & ANDA

End-to-end services with high quality and fast turnaround time providing cost effective solutions
One stop to shop for all the needs in analytical & stability, quality control and regulatory CMC documentation
Package qualified for both China and global submission (“China for China” and “China for global”)

Method Development and Validation

A wide range of chromatography techniques (HPLC, UPLC, GC, and IC) and detection technologies (UV, MS, MS/MS, CAD, ELSD, RI, FID, ECD, ICP, Florescence, etc) to meet the requirements of different types of compounds
Stability-indicating assay and/or related substances methods for drug substance and drug products (tablets, capsules/liquid filled capsules, solution/suspension, powder, beads/coated beads, injectables, topicals, solid dispersion, etc)
Other specific methods, like dissolution (IR, ER, MR), residual solvents, potential genotoxic impurity, enatiomeric separation, cleaning validation, counter-ion, microbiological test, etc
Provide method development experimental design, progress report, method validation protocol and report, method monograph
Phase appropriate approaches – qualified for IND/CTA or NDA/MAA application

Analytical Testing and Release

Analytical support for formulation development and cleaning validation
Reference standard characterization with CoA or full characterization report
Confirmation of structure or absolute configuration determination
Structure elucidation for impurity/degradation product by LC/MS/MS and a variety of NMR spectroscopy
Degradation pathway ascertainment with report for regulatory submission
Leachable/extractable testing

Stability Study

Global registration stability; experimental/probe stability; post-approval commercial stability
Comprehensive services with stability protocol design, program management, storage and testing, data trending/shelf life assessment up to dossier preparation for NDA/MAA application
Storage conditions: 40°C/75%RH, 30°C/75%RH, 30°C/65%RH, 25°C/60%RH and light or customized conditions including 2-8°C, -20°C, -70°C, 25/40, 30/35, 40/20, 50/40 (new)
Qualified stability rooms/chambers (IQ/OQ/PQ and mapping); multiple types of power supply; real time temperature and humidity monitor (dual systems); autodial alert system

Regulatory CMC Documentation

Dedicated regulatory writing group with strong documentation experience and proven track record for global and China submission
CTD-format with version control or customized to meet local requirements
Further integration with IND-enabled toxicology and clinical and regulatory services