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Regulatory Affairs

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  • Focus on Medical Device Regulation

    The EU Medical Device Regulation heralds a new era for the medical technology sector: in future, any company wishing to bring medical devices to market must face the requirements of this new regulatory framework. This implies a sizeable challenge for the many small and medium-sized enterprises in Ge more

  • PharmaLex Group acquires The Degge Group

    The PharmaLex Group, provider of development consulting and scientific affairs, regulatory affairs and pharmacovigilance, has completed the formal merger with The Degge Group, Ltd.  The company is based just outside Washington, DC, in Fairfax, Virginia, USA. The Degge Group’s focus on pharmacoepide more

  • uniQure Appoints Alexander Kuta as Senior Vice President of Regulatory Affairs

    uniQure N.V. announced the appointment of Alexander Kuta, Ph.D., as Senior Vice President of Regulatory Affairs. Dr. Kuta has more than 25 years of regulatory experience within the industry, having previously held leadership positions at Genzyme Corporation, EMD Serono, AMAG Pharmaceuticals and Lant more

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  • Graduate R&D Trainee (f/m)

    For our R&D Hub in Marburg / Lahn, we are looking for two Graduate R&D Trainees, who are interested and willing to develop and grow into roles of increasing responsibility within our organization. The planned starting date is January 1st, 2019 (later starting date possible up until March 1st, 2019). more

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Office of Regulatory Affairs

Office of Regulatory Affairs The Office of Regulatory Affairs (ORA) is the part of the United States FDA that enforces the laws that govern food, drugs, medical devices, and other products that FDA regulates. Organization It is organised ... more


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