Dr. Gordana Bothe Head of Scientific Affairs [email protected] Felix Alt Head of Clinical Operations [email protected] analyze & realize GmbH Waldseeweg 6 13467 Berlin, Germany Tel. +49 30 4000 8100 Fax +49 30 4000 8400 www.analyze-realize.com BVMA member since 2005 Audits passed in 2005, 2007 2010, 2013 and 2016 analyze & realize GmbH was founded in 2000 merging Background Consultancy GmbH (established in 1992) and Phytopharm GmbH. Using our vast experience in the development of medicinal products, dietary supplements, functional foods, food for specific groups, and medical devices, we guide our clients’ decisions with our regulatory & scientific exper- tise combined with creative ideas and smart innovation processes. For more than 20 years, we have been sup- porting more than 1000 customers with global consultancy & strategic innovation services and a unique clinical research center. Within our own study center, we conducted more than 300 clinical trials in fields like weight management, immune, digestive and hearth health, diabetes, etc. At the same time, we have published several books, including PDR-Physician‘s Desk Reference for Herbal Medicines, Die gruene Apotheke and Alternativ Heilen. We are currently establishing a new business sector called „Natural Licencing Matchmaking“ intended to help accelerate innovation and business success. Clinical research and development services ▷ Concept, design, conduct of interventional (phases II-IV) and non-interventional studies, nutritional and pilot studies, clinical investigations with medical devices in a wide variety of therapeutic areas, ▷ Study file setup, EC and CA regulatory submissions, feasibility and site selection, subject recruitment, detailed and proactive project management, trial logistic, clinical monitoring and site management, data management and analysis, Medical writing etc. ▷ Publication in peer-reviewed journals Professional study center with a large subject database, also available as a study site for 3rd party CROs Consulting and Strategic Innovation ▷ Licencing matchmaking ▷ Innovation strategy ▷ Scientific excellence ▷ Product development ▷ Regulatory creativity ▷ Smart market access 22 VMA VMA 23 HISTORY AND MISSION HIGHLIGHTS SERVICES

HISTORY AND MISSION SERVICES - bvma.de · Study file setup, EC and CA regulatory submissions, feasibility and site selection, subject recruitment, detailed and proactive project management,

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Page 1: HISTORY AND MISSION SERVICES - bvma.de · Study file setup, EC and CA regulatory submissions, feasibility and site selection, subject recruitment, detailed and proactive project management,

Dr. Gordana BotheHead of Scientific [email protected]

Felix AltHead of Clinical [email protected]

analyze & realize GmbH

Waldseeweg 6 13467 Berlin, Germany

Tel. +49 30 4000 8100 Fax +49 30 4000 8400

www.analyze-realize.com

BVMA member since 2005Audits passed in 2005, 20072010, 2013 and 2016

analyze & realize GmbH was founded in 2000 merging Background Consultancy GmbH (established in 1992) and Phytopharm GmbH. Using our vast experience in the develop-ment of medicinal products, dietary supplements, functional foods, food for specific groups, and medical devices, we guide our clients’ decisions with our regulatory & scientific exper-tise combined with creative ideas and smart innovation processes.

For more than 20 years, we have been sup-porting more than 1000 customers with global consultancy & strategic innovation services and a unique clinical research center. Within our own study center, we conducted more than 300 clinical trials in fields like weight management, immune, digestive and hearth health, diabetes, etc. At the same time, we have published several books, including PDR-Physician‘s Desk Reference for Herbal Medicines, Die gruene Apotheke and Alternativ Heilen.

We are currently establishing a new business sector called „Natural Licencing Matchmaking“ intended to help accelerate innovation and business success.

Clinical research and development services▷ Concept, design, conduct of interventional (phases II-IV) and non-interventional studies, nutritional and pilot studies, clinical investigations with medical devices in a wide variety of therapeutic areas, ▷ Study file setup, EC and CA regulatory submissions, feasibility and site selection, subject recruitment, detailed and proactive project management, trial logistic, clinical monitoring and site management, data management and analysis, Medical writing etc.▷ Publication in peer-reviewed journals

Professional study center with a large subject database, also available as a study site for 3rd party CROs

Consulting and Strategic Innovation▷ Licencing matchmaking ▷ Innovation strategy ▷ Scientific excellence▷ Product development▷ Regulatory creativity▷ Smart market access

22 V M A V M A 23

HISTORY AND MISSION

HIGHLIGHTS

SERVICES