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3B Biotech Research

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CONTACTS AT 3BBIOTECH.COM

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3B Biotech Research

http://www.3bbiotech.com/phv.html

Phase I / BE Studies. Pharmacovigilance in Clinical Trials. Receipt and registration of AEs / SAEs. WHO / MedDRA coding. Serious Adverse Events Notification. Generation of XML file for Eudravigilance. Management of EV messages. Preparation and notification to CA / EC. Preparation and notification to Investigators. Elements of a Pharmacovigilance system. Qualified Person for Pharmacovigilance (EU QPPV). Continuous monitoring of drugs safety profile. Phase I / BE Studies.

2

3B Biotech Research

http://www.3bbiotech.com/phaseI.html

Phase I / BE Studies. Phase I / Bioequivalence Studies. Thanks to our experience in clinical pharmacology, and a number of clinical studies successfully performed, 3B Biotech is able to provide an overall evaluation of projects development. The deep knowledge of Phase I studies allow us to timely provide comprehensive quotations of studies/projects performed. Single ascending dose tolerability and pharmacokinetics (First in man). Multiple dose tolerability and pharmacokinetics. Phase I / BE Studies.

3

3B Biotech Research

http://www.3bbiotech.com/raffairs.html

Phase I / BE Studies. The regulatory services offered by 3B Biotech are based on three points:. Knowledge of legal-technical aspects. Strategic advise on the PK / PhaseI / Bioequivalence studies and subsequent conduction of Clinical Trials. Support to find a partner for chemical and pharmaceutical development, analytical, stability tests etc. Marketing authorisation applications via National, Mutual Recognition, Decentralized, and Centralized Procedures. In Switzerland following the local rules. 3B Biotec...

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