With the ever increasing focus on safety mandated by health authorities, and the growing complexity of regulations affecting products and processes, regulatory compliance is a more prominent issue than ever. In this evolving environment, it can be difficult to stay abreast of regulatory changes.
The MAPI Group can provide advice and support to help streamline your regulatory and/or pharmaceutical affairs' team. This includes performing regulatory due diligence on a product or global portfolio, review of promotional materials, and providing advice on compassionate use programs (feasibility study, writing of dossiers and PTU) and on development and strategy of registration (MA files : audits, writing and submission).
In addition, the MAPI Group combines comprehensive knowledge of healthcare regulation, an understanding of authorities' expectations, and in-depth experience of both regulatory submissions and information technology.
More information on this service? Visit the site of the Mapi Group Company that specializes in this service.
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