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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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