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“The Cradle” Services for Health Tech and TCM Industry

Life sciences and Traditional Chinese Medicine (TCM) technology are key industries in Hong Kong's Innovation and Technology Development Blueprint, and they also form a core part of China's 14th Five-Year Plan, creating global expansion opportunities for Hong Kong's innovation sector. HKPC's HealthTech and TCM unit, New Industrialisation Division, provides comprehensive “Cradle” support, including market research, product innovation and development, regulatory compliance and product registration, quality assurance, GMP facility design, production line setup, overseas certification, and funding applications. We customise global expansion plans for each enterprise, tailored to its specific needs, resources, and development stage.

Market Research and Product Innovation & Development

HKPC promotes technology upgrades, leveraging industrial internet and common platforms to foster innovation and digital transformation in Healthtech and TCM products, enhancing product quality and production efficiency, and developing new productivity strategies tailored to their needs. Our service includes, but is not limited to: Providing advice on the latest discoveries of active ingredients and frontier topics in life science research fields.

  • Providing recommendations on the latest discoveries and frontier topics in the research of active ingredients
  • Developing innovative products, scientific TCM, or life science-related series products.
  • Piloting current and future products’ market entry, conducting comparative analysis of similar products in overseas markets.
  • Aligning product development timeline and standards to registration requirements.

Product Innovation & Development
Product Innovation & Development

Testing services for products or drugs

HKPC leverages its extensive local and international cooperation network to develop internationally compliant products for enterprises. Our service includes, but is not limited to:

  • Conducting quality and efficacy tests on formulas or products according to local government requirements or international standards, including but not limited to physiochemical properties, quality standards, testing methods and reports, stability test reports, pharmacological and toxicological research, etc.
  • Selecting appropriate cell and/or animal models for mechanism studies of drugs/health-promoting effects.

Study on the effectiveness and quality of drugs or products
Study on the effectiveness and quality of drugs or products
Ultraviolet Fluorescence-based zebra fish model
Ultraviolet Fluorescence-based zebra fish model
In vivo green fluorescent (FITC) protein expression
<em>In vivo</em> green fluorescent (FITC) protein expression

Regulation Compliance and Product Registration

HKPC provides compliance consultation on the local and overseas markets. Our service includes, but is not limited to:

  • Offering regulatory compliance consultation for international market entry products.
  • Handling product or drug registration applications, devising optimal registration strategies.
  • Providing clinical sample production, analysis method development, and stability studies.
  • Responding to regulatory inquiries and follow-up supplementary documentation.

Drug registration
Drug registration

GMP Plant Design

The HealthTech and TCM unit under HKPC's New Industrialisation Division possesses extensive knowledge and experience in production quality management (GMP) and related certifications, making adjustments based on User Requirements Specification (URS). Our service includes, but is not limited to:

  • Conducting preliminary assessment and planning layout for GMP certification.
  • Conducting GMP gap analysis for new/renovated factories/workshops.
  • Designing and installing clean rooms for production and packaging needs.
  • Designing and installing heating, ventilation, air conditioning systems (HVAC), compressed air, and pure water systems.
  • Overseeing the validation plan for the cleanroom and the three major systems
  • Auditing GMP certification equipment suppliers and providing validation testing for clean rooms and the three major systems.
  • Preparing Approval in Principle (AIP), including reviewing Plant Master File (PMF) and Standard Operating Procedure (SoP) documentation.
  • Dealing with health department follow-up enquiries and rectifying required documents according to guidelines.

Plant Design
Plant Design

Production Line or System Construction

HKPC designs and builds artificial intelligence production lines or systems for enterprises, and has been awarded multiple local and international invention awards, which brings Hong Kong technology to the world. In one case study for a TCM enterprise, HKPC proposed AI production under strict GMP production quality management, improving internal and external packaging processes of TCM bottles, increasing productivity by 11 times and production volume by 100%. Our service includes, but is not limited to:

  • Providing an AI automated system design that complies with GMP production quality management standards
  • Using modularised design and a smart programming production system for the packaging of different sizes and textures
  • Employing machine vision systems to ensure high-quality standards of the appearance and the conformation processes, including packaging, instruction sheets, sealing, and anti-counterfeit labels
  • Incorporating a real-time data collection system (production, equipment, quality, and energy data) to monitor automated system performance, in preparation for the establishment of the Industrial Internet of Things (IIoT)
  • Utilising an easy-to-use Human Machine Interface (HMI)
  • Employing industrial robots with other devices for high-speed processing, transportation of various irregular materials and precise allocation of tiny bottles into thermoform packs without disrupting the surrounding area

Drug packaging and assembling robotic arm system
Drug packaging and assembling robotic arm system

Intelligent visual packaging quality assurance systems
Intelligent visual packaging quality assurance systems

Overseas Certification

HKPC enhances enterprises’ product and service quality to fulfil international standards of production. Our service includes, but is not limited to:

  • Current Good Manufacturing Practices (cGMPs) for Food and Dietary Supplements, FDA US
  • NSF/ANSI Good Manufacturing Practice (GMP)
  • Good Manufacturing Practice (GMP) for Medicines, TGA Australia
  • Licence for Pharmaceutical Manufacturers (PIC/S GMP)
  • Health Food Product Manufacturers (ISO 22000, HACCP)
  • Good Manufacturing Practices for Cosmetics (ISO 22716)
  • Medical Device - Quality Management System (ISO 13485)

Certification Application Assistance Service
Certification Application Assistance Service

Funding and Policy Support

HKPC provides funding application support to local HealthTech and TCM enterprises, facilitating their international market expansion, including but not limited to:

Government funding programs
Government funding programs

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