R&D Service
From drug discovery to commercialization of the "one-stop" service platform
CMC Service
Caremo is dedicated to delivering high-quality, efficient, and integrated one-stop CMC (Chemical, Manufacturing, and Controls) services. Our offerings include: CMC Development for Generic Drugs & Small Molecule Innovative Drugs, Feasibility Assessment and Project Initiation, API & Formulation Process Optimization and Development, Pilot-Scale and Commercial-Scale Production, Stability Studies, Clinical Sample Manufacturing (GMP Compliance)
Caremo provides full process API CMC services from pilot study, process development, registration. Following the QbD concept, we provide innovative process R&D service for cooperation partners to ensure product quality as much as possible, reduce and control risks.
Service Items
· Screening of crystal form/salt form, characterization of physical and chemical properties
· APIs process development, optimization and production for new drug in preclinical or clinical stages
· API manufacturing process development, optimization, production and application (DMF)
· API manufacturing process risk assessment and control, safety evaluation
· API and intermediates quality study
· Analytical method development and validation
· Manufacturing technique transfer and validation
· Impurity identification and separation
· API stability study
Caremo is committed to providing one-stop preparation CMC services for cooperation partners, covering project initiation study, process study, quality study, registration application, etc. Caremo has established a number of pharmaceutical R&D technology platforms, has in-depth research in a variety of complex pharmaceutical fields to meet the diversified needs of cooperation partners.
Service Items
· Preprescription study
· Formulation technology screening and optimization
· Preparation scale up study
· Preparation quality study
· Preparation Pilot scale study
· Preparation technology transfer and process validation
· Preparation stability study
· NDA and ANDA application documents writing (M4 format)
Caremo’s analysis team have rich project experience, and we can provide cooperation partners with high quality and efficient drug analysis service. According to customer’s requirements and project status, we can make flexible program plans to complete the development and verification services of analytical methods for well-known projects，such as high-tech barriers, high difficulty and complex chiral drugs.
Service Items
· Compound and its preparations quality study
· Related substances analytical methods development and validation
· Isomer analysis method development and validation
· Genotoxic impurity analysis method development and validation
· Residual solvent analysis method development and validation
· Content determination and analysis methods development and validation
· Dissolution determination method development and validation
· Stability study
Service Items
From R&D to commercialization, Caremo takes the dual wheel drive of R&D and industrialization, takes R&D as the support, takes industrialization as the goal, and provides customized R&D and industrialization solutions according to the diversified needs of different customers, covering API and preparation.
We also ake complex preparation technique as the entry point, accelerating CDMO service layout, aiming to establish high standard R&D platforms and international professional technique teams. We continuously enrich and reinforce our end-to-end capabilities to provide cooperation partners fast and reliable CDMO service, and assist to achieve API DMF and/or drug NDA commercialization.
Service Items
Caremo provides assessment, planning and feasibility consultation, as well as developing recommendations during the key work of CMC R&D to ensure the quality of submitted documents meets requirements. We can customize practicable registration strategies for cooperation partners, help them avoid potential registration risks. Our professional team can empower your R&D program and help you occupy the market quickly.
Service Items：
(1) Acting on native companies preparing NDA/ANDA documents and submiting to NMPA
(2) Acting on native companies preparing NDA/ANDA documents and submiting to US FDA
(3) Acting on abroad companies preparing NDA/ANDA documents and submiting to NMPA
Service Advantages
Professional and experienced technical team
We have a R&D technical team of more than 600 people, 30% of them have master's degree, and more than 80% of them have over five years experience in drug R&D and industrial production. The main technicians used to be employed by large and medium-sized pharmaceutical companies or R&D institutions，they have rich successful experience in CMC development.
500+
personnel
30%+
Master degree
80%+
Five years of experience
Service Advantages
Precise and comprehensive facilities
At present, we have a more than 10000+㎡ R&D center invested, equipped with more than 600 advanced equipment, such as LC/MS, GC/MS, NMR, XRD, HPLC and full set of solid & liquid & external preparation pilot equipment.
Service Advantages
Sound management system
Caremo has established a sound quality management and project management system, got ISO9001 certification and more than hundred the SOP to fully guarantee the compliance, efficiency and coordination of the company's operation. Caremo adopts the project director system, strictly executes the project plan and focuses on key nodes and milestones, QA&QC teams control the whole process. We try our best to push forward the project process with high quality and efficiency under the compliance system, and ensure the authenticity, scientific and traceability of the data.
Follow us
Contract Us：
Add：Building C6, No. 9, Weidi Road, Qixia District, Nanjing
P.C：210046
Tel：025-85760569
M.P：bd@caremo.com.cn
