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  • Medicilon Cmc Services - China

    price: 1.00 Dollar US$

    Research on Quality Control

    1.The development and validation of analytical method

    Develop and validate the analytical method according to the features of dosage form and the APIs.

    1)Method validation for enantiomers
    2)Method validation for impurities
    3)Method validation for content uniformity
    4)Method validation for assay
    5)Method validation for microbiology
    6)Dissolution method validation

    2.Quality research of the products

    Quality research base on the character of dosage form and compound and relevant guideline.

    4)Related substances
    7)Dissolution curve (12 units/lot)
    8)Moisture or loss on drying.
    9)Microbiological test

    3.Determine the specification for final products

    1)Analytical reports
    2)Protocol of quality standard

    Stability Study

    Accelerated and long-term stability test based on ICH guidance and CFDA guidance
    Forced Degradation Testing
    Accelerated Stability Test
    Long-term Stability Test

    Consistency Evaluation

    The development and validation of analytical method
    Consistency evaluation of formulation by quality specification
    Make solution base on evaluation result

    IVIVC of the Product

    We provide the service of IVIVC of the product.
    Registration and Submission

    Data processing for the registration dossier
    Compiling and translation of the registration dossier.
    Registration & Submission

    Our CMC experts with decades of experience are familiar with various ICH and CFDA regulations and guidelines. We have helped many clients to complete their pre-formulation and formulation studies and provided reliable data for the regulatory submissions. We have already successfully assisted many clients to complete the 1.1 class, 3.1 class and 6 class new drugs for CFDA application.

    Company Contact:

    • Phone: +862158591500

    • Address: 585 Chuanda Road,Pudong,Shanghai201299,China, Shanghai, Pudong New Area, China

    • Email: Email

    Published date: September 1, 2016 -

    • Business Description: Medicilon offers fully integrated pharmaceutical services for the global scientific community. We focus on providing an exceptional client-centered experience and advancing the drug discovery process.

      Since the founding of our company in 2004, our integrated services across biology, chemistry and preclinical services are uniquely designed to help clients developing their research and discovery programs from the initial idea stage to the IND filing phase.

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