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Vera Smorchkova
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Work Experience
Juniour Pharmacovigilance Specialist
Oct 2018 - Present · 6 years and 2 months
Mar 2021 - Apr 2023 · 2 years and 1 months
Safety & Pv Submission Specialist I
Oct 2022 - Apr 2023 · 6 months
Safety & Pv Submission Specialist I
Mar 2021 - Sep 2022 · 1 years and 6 months
Company Details
Smooth Drug Development offers a full range of clinical trial, drug registration and post-marketing services, including consulting, development of registration strategy, conduct of clinical studies and pharmacovigilance in Europe and Asia. We cover wide geography: -Russia -Belarus -Kazakhstan -Latvia -Lithuania -Estonia -Serbia -Slovakia -Hungary -Germany -Spain -Turkiye -India -Pakistan -China Our company implemented the principle of "one stop service" when all activities from planning to product registration are performed consistently under the control of a team of professionals. According to the requirements of ISO 9001:2015, in case of outsourcing of vendors we manage their activities as our ones and are fully responsible for the results. Our Clients are leading pharmaceutical, biotech and R&D companies located in Europe, US, CIS and Asia-Pacific region. We offer drug development services: -Consulting center -Pre-clinical research -Clinical trials -ePRO -eTMF/eISF -Drug registration -Post-marketing surveillance -Pharmacovigilance -Training center We are experts in clinical services: -Project management -Medical writing -Feasibility and site selection -Regulatory support -Data management -Logistics and storage -Clinical monitoring -Medical monitoring -Pharmacovigilance -Bioanalytical and central laboratories -Biomedical statistics -Clinical study report -GCP audit Smooth Drug Development has unique IT solutions for clinical trials which help to speed up clinical trials processes and daily activities. Smooth CTMS includes the following modules: -EDC/eSource/IWRS -eTMF/eISF -ePRO -Learning / QMS -Personal Folder -Clinical Monitoring Smooth Drug Development has been ISO certified: -ISO 9001:2015 Quality Management Systems -ISO 27001:2013 Information Security Management Systems -ISO 22301:2019 Business Continuity Management Systems Please contact us at bd@smoothdd.com to learn more about Smooth Drug Development capabilities.
Year Founded
2008
Social Media
Linkedin
Industry
Biotechnology Research, Pharmaceutical Manufacturing
HQ Location
Suite 400 Centerville Road Wilmington, Delaware 19808, US
Keywords
Animal studiesClinical trials phase I-IVBioequivalence studiesBiosimilarsDrug dossier preparatioDrug registratioRegulatory support/CTAPharmacovigilanceBioanalyticsClinical monitoring
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