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BlueReg Group Publishing & Submissions

Case studies

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18 November 2020

System Validation Publishing Software Upgrade

A global pharmaceutical company specialising exclusively in the research, development and marketing of medical solutions for dermatology entrusted BlueReg (BR) to validate its Publishing Software.   With the objective to proceed with a major upgrade of their Publishing tool, and…

Case studies

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15 October 2020

Publishing and Submission of a grouped application of Type IAIN Variations (IA-Supergroup)

A global specialty-driven biopharmaceutical group focused on innovation and specialty care entrusted BlueReg to co-ordinate the publishing and submission of a grouped application of Type IAIN variations. This impacted several different products from the same Marketing Authorisation Holder, with different…

Case studies

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29 September 2020

Publishing & Submission of eCTD baselines through the national procedure in Europe

A global specialty-driven biopharmaceutical group focused on innovation and specialty care, entrusted to BlueReg the the preparation and coordinateion of 60 eCTD Baseline submissions for registration in Europe through the National Procedure (NP).

Case studies

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14 September 2020

Publishing – Marketing Campaign in US, EU, CA & CH

A global pharmaceutical company specialising exclusively in the research, development and marketing of medical solutions for dermatology recently entrusted to BlueReg the publishing of an initial Marketing Authorisation Application (MAA) dossiers for Europe, Canada & Switzerland + Responses to Questions…

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Welcome to BlueReg, an international consulting company for the pharmaceutical industry, specializing in development, regulatory affairs, economic affairs, quality and pharmacovigilance. We have built long-term partnerships with many clients by offering them “tailor-made” services guaranteeing expert advice and efficient solutions, thus supporting their projects towards success.

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