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GMP Contract Manufacture
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We offer the following services:
- operation to GMP/PICs regulatory requirements of the TGA, FDA and EU
- a facilty licensed by the TGA for Manufacture of Therapeutic Goods
- APVMA Category 1 license for aseptic fill and
- operate from a GMP facility with high quality process and validated systems.
Toll contract manufacture with formulation and compounding to fill and finish with:
- GMP review of process
- process and equipment validation
- formulation
- compounding and filling
- lyophilisation as a speciality
- sterilisation
- packaging
- quality analysis and release
Additional services:
- pilot, scale-up and commercial batches
- gamma, steam and dry heat sterilization
- laboratory level formulation development
- GMP and ICH M4Q regulatory consultation and compilation of
the Common Technical Document (CTD)
- consultancy and coordination of Q7A GMP synthesis of APIs
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