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| Company Profile |
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Bio-Chem Engineering LTD provides process development, validation, GMP and engineering services.
Our mission is to lead and assist young as well as established companies in the pharmaceutical, biotechnology and medical device industries.
Our engineers escort the project from the stage of fund raising and clinical trials, process development, process engineering, validation, GMP consulting, FDA / CE approval, engineering documentation as well as planning and constructing an authorized and qualified production site.
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| Our Services |
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> Product development and manufacturing
according to cGMP
> Process engineering and design
> Clinical trials batch production according
to FDA/CE compliance
> Validation requirements analysis
> Validation policy documentation
> Installation, operational and performance
qualification protocols
> Process validation, software validation
and cleaning validation/verification
> GMP consultancy and GMP training
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