Synthetic route scouting in lab

Pilot synthetic process optimization

Full scale synthetic process optimization

Identification of regulatory start material

Impurity profile studies: organic impurities, inorganic impurities, elemental impurities, residual solvents, degradation impurities, potential genotoxic impurities

Genotoxic impurity studies: Prediction of genotoxicity of impurities based on Derek/Sarah software, and Limit determination for genotoxic impurities based on ICH M7 guidelines

Impurity characterization: Impurity preparation, separation, and structure elucidation by pre-HPLC, LC-MS, GC-MS, FT-IR, NMR, etc.

Impurity control strategy: understand the fate of impurities, including source, purge and control strategy, and determine the impurity profile and limits based on safety risk assessment

Chirality method

Particle size distribution （PSD）

Ion content and residues

Elemental impurities

Low content genotoxic impurities (GTI)

Residual solvents

Polymorph determination

Related substances/assay

Identification and control of CQA

Identification of CPP and control strategy based on QRA

Full scale process validation

Forced degradation and stress tests (Light, acid, alkali, oxidation, high temperature, and high humidity)

Accelerated and long term stability program as per ICH Q1 and NMPA guidelines (40°C /75%RH, 30°C /65%RH, 25°C /60%RH, 5°C)

Follow-up stability program in the commercialization phase

Establishment of impurity control strategy

Specification development and justification

CMC document drafting

Trouble shooting of potential CMC deficiencies.

IND/NDA filing

Full GMP compliant product manufacturing

Excellent data integrity management system

Proved tracking record on Health Authority inspection and customer audits

Strong integration capability to ensure stable and on-time delivery

Comprehensive ESG management system