CDMO SERVICES
Everesta specializes in providing a wide range of customized services, including process development, manufacturing, and drug packaging catering to the requirements of advanced intermediates, APIs, and formulations across pre-clinical, clinical, new drug approval, and commercialization stages. Building on this foundation, we provide tailored production services that can scale from kilograms to tons, according to the specific needs of each project.
API CDMO Services
- 1. Design and screening of API and intermediate process routes
- 2. Comprehensive quality research, process development, and optimization
- 3. Clinical sample production under GMP conditions (Phase I~III)
- 4. Scale-up production to commercialization (milligrams to 1000 tons)
- 5. CMC research services
- 6. eCTD dossier preparation (supporting NMPA, FDA, IND/NDA)
- 7. Customized production services for MAH
Pharmaceutical Formulation CDMO Services
- 1. Pre-formulation studies
- 2. Formulation development, process scale-up
- 3. Non-GMP pilot batch production
- 4. Analysis method development and validation
- 5. Development of various commonly used dosage forms
- 6. Transfer and validation of analysis methods, and stability studies
- 7. Clinical sample production under GMP conditions (Phase I~II)
- 8. Preparation of eCTD dossier (supporting NMPA, FDA, IND/NDA)
Pharmaceutical Formulation CDMO Services
- We can provide all customized CDMO services and track the entire process from drug project initiation and research to drug development, technology transfer, and process validation, ensuring that internal data complies with regulatory requirements of various regulatory agencies. Additionally, we are familiar with official communication channels with various drug regulatory authorities, enabling us to effectively grasp review requirements and expedite drug market entry.