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Compliance Consultation Service for Pharmaceutical 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
  • 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)
 

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
Compliance Consultation Service for Pharmaceutical Industries
Compliance Consultation Service for Pharmaceutical Industries
Compliance Consultation Service for Pharmaceutical Industries