RESEARCH PROJECT 2
RESEARCH INTO ELECTRONIC SUBMISSIONS FOR REGULATORY APPROVAL
(BIOTECHNOLOGY & PHARMACEUTICALS INDUSTRY) - AKOS HEALTHCARE GROUP
LTD
This research was undertaken as it is increasingly common for regulatory
bodies to accept electronic submission as the only form for formal approvals.
This may be significant in the biotechnology and pharmaceuticals sector where
there is a growing pressure to submit applications by electronic means to
regulatory authorities. Whilst benefits of electronic submission are recognised
by various stakeholders in the biotechnology and pharmaceuticals industry, the
impact of it being mandatory will no doubt vary across the sector. Such a move
could have a significant impact on the growth and development of the
biotechnology and pharmaceuticals industry. Focusing on small and medium-sized
biotechnology and pharmaceuticals organisations in the UK, this research studied
the implications of electronic submission, identified any potential barriers,
and investigated how these barriers might be overcome.
Electronic Submissions for Regulatory Approval
Executive Report Click here
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