Sunshine Biopharma to negotiate with several Contract Research Organisations.
M2 PHARMA-September 5, 2014-Sunshine Biopharma to negotiate with several Contract Research Organisations
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Sunshine Biopharma, a pharmaceutical company focused on the research, development and commercialisation of drugs for the treatment of various forms of cancer, is presently negotiating with several Contract Research Organisations, it was reported yesterday.
The company is negotiating with the intention of engaging one of them to initiate, compile and manage a regulatory master drug file for Adva-27a, the company's flagship anticancer compound. A master drug file includes all of the information that regulatory agencies require as part of the drug development and approval process.
Dr. Steve N. Slilaty, CEO of Sunshine Biopharma, said, 'Engaging a CRO is the next step in our Adva-27a drug development programme. We are delighted to have arrived at this advanced stage in the development of our Adva-27a. The CRO will compile the testing results conducted to date, follow and document the GMP manufacturing process, manage the large animal studies and file with the appropriate regulatory agencies for go-ahead with Phase I human trials.'
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|Date:||Sep 5, 2014|
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