C. Lim Consulting Pty Ltd.
Pharmaceutical GMP Consultant in:
Release for Supply, GMP Compliance, GMP Validation, QA & QC Solutions and GMP Training.
C. Lim Consulting Pty Ltd has in-depth and broad experience in pharmaceutical GMP consulting and veterinary GMP consulting to the pharmaceutical and animal health industries. The consultancy has worked with many multi-national companies, including USA, Canadian, UK, European, Asian and Australasian companies, to bring them to TGA, EU/PICS, FDA, SFDA, APVMA (Australian) and ACVM (New Zealand) GMP requirements. This consultancy has also provided consultancy services to the Medical Device Board and the National Pharmaceutical Control Bureau, Ministry of Health, Malaysia.
The consultancy provides broad-range consulting for Good Manufacturing Practice (GMP), TGA and APVMA licences for Release For Supply service, Pharmaceutical Validation, Pharmaceutical GMP inspection/audit, GMP training and documentation, Quality Control (QC) and Quality Assurance (QA) requirements and Good Laboratory Practice (GLP) for TGA (Australia), New Zealand, US FDA, SFDA (China), EU/PICS, Asian and WHO GMP.
C. Lim Consulting Pty Ltd provides consulting services for the manufacture and handling of:
- Release For Supply service for TGA and APVMA products.
- Release for Supply service for Clinical Trial products.
- Conformance Review for TGA and APVMA products.
- Pharmaceutical GMP inspections/auditing.
- GMP training and documentation.
- Pharmaceutical validation.
- Solid dose products (tablets, capsules, powder).
- Creams and liquids.
- Aerosol products.
- Sterile and non-sterile products manufacturing and packaging.
- Food product manufacturing and packaging.
- Veterinary products.
- Temperature sensitive product storage and shipping requirements.
- Documentation system set-up, update and upgrade.
- Stability studies and monitoring.
- GMP building requirements.
- Quality and Technical Project management.
- QC and QA requirements.
- GLP requirements.