API manufacturing process development, optimization, manufacturing and submission (DMF)
Technology transfer and process validation
Process risk assessment and control
Process safety assessment
Quality research of intermediates
Identification and separation of impurities
API stability studies
Screening of crystalline and salt types, etc.
Pre-formulation study
Formulation process development and optimization处方工艺开发和优化
Lab scale-up and pilot scale-up
Clinical sample preparation under cGMP condition
Stability study
Process validation and transfer, etc.
Development of test methods for starting materials, and establishment of submission standards
Development of test methods for common reagents
Comprehensive QbD-based drug quality research
Development of test methods for potential genotoxic impurities
Development of test methods for anion and cation residue
API stability studies (stress, accelerated, long-term)
Crystal form testing
Structure confirmation and calibration services for impurities and working standards
Services of routine instrumental analysis (HPLC, GC, LCMS, LCMSMS, GCMS, ICPMS) and physical and chemical testing (melting point, specific rotation, pH, water content, loss on drying, residue on ignition, heavy metals, chlorides, sulfates, etc.)
With a registration submission team with rich experience at home and abroad, familiar with the regulations and policies of China, the United States, Europe and other countries, Neoleading Pharma has helped clients complete 100+ projects in IND phase,and we can provide clients with clinical trial application, different phases of clinical trial, new drug application (NDA), abbreviated new drug application (ANDA), and all phases of CMC registration support services.
Preparation, drafting and technical audit of CMC submission dossier (IND/CTA/NDA in US, Europe and China).
Ensure the quality of submissions to meet the requirements
Provide advice and support in compliance with regulatory requirements
