Medicilon is a comprehensive CRO in the field of biology and medicine. We commit to provide integrated and efficient service. Our unique “tailored” process development mode also fully embodies this idea. We can collaborate with the clients to get target compound as soon as possible.
Early Phase Development and Clinical Manufacturing
Medicilon is a comprehensive CRO in the field of biology and medicine. We commit to provide integrated and efficient service. Our unique “tailored” process development mode also fully embodies this idea. We can collaborate with the clients to get target compound as soon as possible.
Process R & D team has extensive experience in the following
- Commercial Synthesis Route Scouting
- Commercial Process Development and Optimization Through DoE and QbD
- Stepwise Unit Operation Studies and Defining Critical Process Parameters
- Impurity Profiling, Fate and Control
- GMP Starting Material Definition
Commercial Manufacturing
Process Chemistry Research and Development
Medicilon is your reliable partner in commercial manufacturing. We have established cooperation with the commercial production plant and set up facilities to support all aspects of the supply chain from raw materials sourcing to finished products export. Our team has proven to clients that we ensured each project with high quality, timely and full implementation.
Medicilon is also well experienced in project management, dedicated customer service and professional technical services. Our team has demonstrated to clients that prospective work in the early stage of clinical research really advanced through commercial production stage by accurately undertaking technical information transfer, using our API integrated technology research, development and production capacity, and strictly controlling the lifecycle management.
Medicilon also has production facilities in the reliable partners’ pilot and plant, which enable end to end services from early development to commercial production. It helps to shorten time and to provide sustained and cost-effective service. Our facilities can scale up all types of reactions, including asymmetric hydrogenation, air and water sensitive metal catalytic reactions, high temperature, high pressure, low temperature and oxidation reactions.
Process Analytical Science
Our process analytical sciences group provides support for research, development, and commercial production.
At Medicilon, the importance of analytical support in pharmaceutical development and manufacturing is well understood. We provide our clients with analytical method development and all other services required to support their regulatory needs.
Services Offered
- Analytical Method Development, Qualification and Validation for
- Assay
- Related Compounds
- Water Content
- Chiral Analysis
- Residual Solvents
- Trace Metals Analysis
- IPC and Release Testing
- Impurity Isolation and Structure Elucidation
- Reference Standard Qualification
- Stability Studies
- PGI Method Development, Validation and Testing
- Specification and Other Regulatory Filing Documentation Preparation
We have the following key instrumentation to support our analytical activities
- Chromatography: UPLC, HPLC, LC-MS, GC, GC-HS
- Solid State Characterization: DSC, TGA, XRPD, PSD, Polarized light microscopy
- Elemental Analysis: ICP-OES
- Identification: NMR, FT-IR
- General Testing: KF, UV-Vis, Polarimeter
Project Management
Our experienced project management group is customer-focused, responsive and flexible to ensure successful completion of all project milestones and your overall satisfaction.
We understand the importance of an experienced project management function for clients. Our dedicated group coordinates essential activities of the multi-disciplinary project team inclusive of business development, process R&D, manufacturing, analytical/QC, QA, procurement, and regulatory during the lifespan of a project.
We know our customers are invariably focused on time, service and quality. Therefore, we focus on establishing the clear communication channels between Medicilon and our partners. Our project management group develops highly structured planning with clear milestones, provides timely project updates and ensures adequate resourcing to achieve project goals and milestones. The assigned project manager will serve as your nodal point of contact at Medicilon for all projects activities.
The primary objective of project management is to ensure successful project delivery and customer satisfaction while meeting all our clients’ needs on quality, quantity and timeline.
