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Customers & Cases

Many pharmaceutical companies, ranging from top 25 pharma companies to micro, small & medium sized enterprises (SME) already benefited from our consultancy, services and solutions. Our clients are operating either in the field of innovative-, generic- or biological medicine and also include Health Authorities and software vendors use our services. We can also work as a subcontractor for other consultancies and vendors.

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Seeking approval for a marketed product

Lean and right first time content creation and electronic submission management A young pharmaceutical company wanted to register their first initial MAA for the EU. It concerned a research-oriented company with
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Tool implementation

At various companies Qdossier has been involved in implementing new process supported by tools and new tools supported by processes. In both cases, the human factor is incontrovertibly important and often underestimated.
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Structured content management

Can data drive documents and dossiers? A major global pharmaceutical company wanted to check whether it was feasible to manage data in a database; where the data was used to
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End-to-end RIM progam management incl. IDMP

Process driven end-to-end Regulatory Information Management. For a mid-sized global client with a wide range of pharmaceutical products and medical devices, mainly IV solutions and clinical nutritionals,
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Regulatory Operations support

On-site and remote regulatory operations support A Tier 1 pharmaceutical company wanted to hire additional support for their Regulatory Operations Department. Initially these services were to be provided on site.
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Document and data migration from multiple repositories

On-site and remote support Mid-size globally operating innovative pharmaceutical companies wanted to migrate from multiple repositories (e.g. Documentum, SharePoint and/or Windows file share) to a new
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