CN

Solution

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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