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LANGUAGE
Compliance Consultation Service for Chinese Medicine, Pharmaceutical, Health Food and Medical Device Industries
Extensive knowledge and experience in compliance on GMP or related requirements
Service details:
Consultancy service on regulatory affairs (local standards)
- Manufacturer Licence for proprietary Chinese medicines (GMP for pCM)
- Compliance for Advanced Therapy Products (ATPs)
Consultancy service on regulatory affairs (international standards)
- 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 (ISO22000, HACCP)
- Good Manufacturing Practices for Cosmetics (ISO22716)
- Medical Device - Quality Management System (ISO 13485)
Advisory service on the design of manufacturing site in compliance with GMP
- Plan and design clean room facilities in accordance with the manufacturing and packaging needs
- Water purification system; Heating, ventilation, and air conditioning (HVAC) and compressed air supply
- Validation for the clean room, the Water purification system, HVAC and compressed air supply
Product registration service
- Evaluate the necessary documents and experimental reports for fulfilling the registration requirement
- Schedule and arrange the registration plan upon client’s need
- Handle client’s product registration and conduct the necessary testings
- Review the experimental reports and prepare the documents (safety, efficacy and quality tests) for submission to regulatory authority
- Follow-up on the inquiries from the regulatory authority
Compliance Consultation Service for Pharmaceutical Industries
Compliance Consultation Service for Pharmaceutical Industries
Compliance Consultation Service for Pharmaceutical Industries
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