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        In Tai Heng, we understand our customer’s needs of bringing pharmaceutical products from bench top to market with utmost efficiency, minimum risk, and sustainable reliability. That is the reason we proudly offer our Total Solution, by bring together our expertise on project management, process development, quality and regulatory management with our customer early on, and applying this Total Solution consistently across the entire Product Lifecycle, from its benchtop development to post commercialization improvement. Our goal is to drive our customer’s product through regulatory approval faster and better, and maintain such competitive edge well beyond the product on the market.

        Integrated Solution for Pharmaceutical Development & Product Life Cycle Management

        Manufacturing Improvement

        Monitor & track any changes made after product approval, internal and external, to ensure our customer’s product in compliance with most updated regulatory requirements all the time.

        Drug Establishment Registration & Change Control
        API/Drug Product Commercial Label Changes
        Impact Analysis on Changes made on approval product
        Product Improvement Study and Revalidation/Revarification
        Periodic Product Quality Management System Evaluation
        Product Quality Matrix Report/Annual Report Draft/Compilation/Submission
        Batch Size, Manufacturing Cost of Goods, and Manufacturing Capacity Evaluation
        Life Cycle Management of Submitted Documents

        Integrated Product Design Module

        Conduct individualized based analysis on key product attributes and define overall regulatory strategy with customer at early stage to mitigate risks

        API/Formulation QTPP Design
        API/Formulation CQA Identification
        API Physical Property Characterization & Impact Study
        API Synthesis Route Determination & Impurity Profile Study
        Pre-formulation/De-formulation Studies
        Formulation & In Vitro Dissolution Method Development
        Preliminary Stability Study & Forced Degradation Studies
        Risk Assessment on Development Strategy & QoS Integration

        GMP Quality Management System

        Tai Heng’s Quality System is established on our solid scientific knowledge and proven regulatory understanding. Our quality management team work meaninglessly with the rest of Tai Heng staff to ensure our quality system is effectively & properly implemented, and GMP principle on authenticity, traceability, and reproducibility will never be compromised.

        Change Control System
        Investigation and CAPA System
        Fully Equipped QC Laboratory and CDS System
        GMP Document Management System
        Continuous Staff Training/Qualification
        Facility & Equipment Life Cycle Management System
        Supply Chain Audit & Periodic Quality Review
        Regulatory Evaluation and US FDA Inspection Mangement

        Product Registration/Submission

        Assist Sponsor to define the most efficient regulatory strategy based upon existing development status and available information, and achieve best application outcome.

        International Regulatory Support (US FDA, Health Canada, EDQM etc.)
        Document Management for IND/NDA/ANDA/DMF/CEP
        Drug Establishment /Drug Product Registration
        CTD Document draft, compilation and review
        IND/NDA/ANDA/DMF/CEP Submission & Post Submission Management
        Deficiency response strategy.
        Domestic Regulatory Support
        Due Diligence Review on Import Registration
        Import Registration Submission and Management, including Translation
        Generic Drug Re-evaluation Submission & Management

        Manufacturing Process Optimization

        Define and design Process Control Strategy, with sound analytical methods and sampling plan to ensure its efficiency, robustness, and productivity.

        Determine API/Formulation Critical Process Parameters
        DOE on Manufacturing Process
        QbD based Process Optimization
        Control Strategy development, including Sampling Plan & Analytical Methods
        Comparative Dissolution & Process Impact Studies
        ICH based Stability Studies & Packaging Configuration Studies
        Risk Assessment on Manufacturing Strategy & QoS Integration

        Scale Up & Tech Transfer

        Conduct on-site audit and proper tech transfer, to ensure both engineering batch(es) & submission batch(es) are meeting the most stringent US FDA regulation and other compliance requirements.

        Manufacturing Site Audit and Risk Assessment
        GAP Analysis on Manufacturing Process and Analytical Testing Capacity/Capability
        Design Scale Up & Tech Transfer Protocol
        Design Cleaning Validation Strategy and Protocols
        Design Analytical Method Transfer Protocols
        Design Process Validation Protocols (API & Formulation)
        Design Pre-submission and Post Approval stability protocols
        Execute & Manage Engineering Batch Manufacture
        Batch Size, Manufacturing Cost of Goods, and Manufacturing Capacity Evaluation
        Scale Up/Tech Transfer Report & QoS Integration
        Formulation Development Service
        Quality & Regulatory Management
        API Development Service
        Analytical Testing

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