China CRO Company,Preclinical research services

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Process Development Services

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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 Development Services

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.
    Professional R & D team, adequate resources, perfect production equipment and the latest advanced production facilities, make Medicilon, as your long-term strategic partner, to provide efficient, reliable service and high valuable intermediates and APIs. We understand your needs to robust, cost-effective process for large scale manufacture. Our team has rich experience on process optimization and developing new, safe and environmentally-friendly process route.

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 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.

Advantages

Whole Series of Reactors

Medicilon has flexible production resources and production capacity of GMP, with multifunctional reactors from 5L to 10000L of different materials. We could meet the demand of various projects to manufacture products from early phase development to preclinical and clinical stage.

Rich Experiences

Well-equipped research & development center, kilo-labs & pilot plant are fully GMP operational. We could run multi-species of reactions, develop fit-for-purpose manufacturing process for advanced intermediates, registration starting materials and API (Drug Substance) and DP (Drug Product) from gram to MT scale. Our highly motivated, experienced and dedicated teams can provide innovative solutions from early development through to competitive commercial supply.

24/7 Operations

The cooperation site operates 24/7 and is supported by on-site process chemists, process engineering, QC and QA, and logistics teams to support the operations.

Tailored Package

Our flexible approach enables customers to benefit from tailored packages that focus on clients’ needs and balance their needs in terms of speed and cost.

Integrated Services

Our services are designed to help our clients to shorten the time and lower the cost of drug development and manufacturing by providing fully-integrated, cost-effective and efficient outsourcing solutions from preclinical batches through to commercial supply.

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