Analytical Development 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 such as 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