SPI USA : Consulting Services : Pharma & Biotech Consulting - Upstream and downstream process development, CGMP compliance

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SPI USA can provide your organization with the necessary pharmaceutical and biotechnology expertise required to remain competitive and dynamic. We have developed particular expertise in the following areas:

Upstream and downstream process development, process optimization and process validation.
Facility design, equipment selection and qualification, and vendor auditing as they relate to CGMP compliance.
Design, preparation and review of documents in support of 21 CFR CGMP compliance, including SOPs, Master and Batch Production Records, validation protocols and validation reports.
Feasibility assessment studies as they pertain to bioscience related areas such as facility construction and new product development.
Strategic bioscience partnerships on international and national levels.
Technology transfer between academia and industry.