Tianjin GoalGen Biotechnology Co., Ltd. is the sole subsidiary of Clin-nov Medical,a subsidiary of Asymchem(002821.SZ).    Tel:+86-022-25322880

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Preclinical research project management services

GoalGen Biotechnology provides a full-process drug development project management service to guide the development of new drugs around clinical application value

  • R&D path planning and evaluation

  • New drug-based drug evaluation service

  • New drug preclinical research design&Executive supervision&Risk management

  • Production of a full set of IND filings

  • New drug registration report&Government affairs

  • Import drug registration

  • R&D path planning and evaluation
    Guide new drug development around clinical application value
    Investigate the research and development of similar drugs at home and abroad, and visit clinical experts in the field of indications to assess the possibility of approval for indications.
    New drug-based drug evaluation service
    Judging the medicinal properties from the perspective of reviewing experts, timely stop loss
    Review the trial plan design, organize a drug evaluation meeting, evaluate the test results, and comprehensively judge the drug properties
    New drug preclinical research design & implementation supervision & risk management
    Ensure the scientific nature of the development process
    Select the most cost-effective Chinese pharmacology and toxicology CRO
    Design preclinical studies based on clinical research protocols
    Combine years of practical experience, training original record writing requirements, and supervise research process compliance
    Production of a full set of IND filings
    Meet the requirements of Circular 50, IND application for clinical research documents
    Draft & revise & retouch profiles based on reviewers' reading habits;
    Review and revise the application materials for pharmacy, pharmacodynamics, toxicology, and pharmacokinetic research;
    Design clinical research practice documents in conjunction with the latest regulatory requirements
    New drug registration report & government affairs
    Organize Pre-IND/NDA meeting; submit the application materials; follow up the review process; accompany the site assessment; reply to the comments
    Import drug registration
    Assess the integrity of import data; organize & submit submissions; follow up review process
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