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QBD GROUP

QBD GROUP
簡介
QbD Group is an international consulting company, a reliable life science partner throughout the entire product lifecycle, from idea to patient, specializing in every expertise related to: - Qualification & Validation - Quality Assurance - Regulatory Affairs - Clinical Solutions - Laboratory Services - Business & Communications - Software Solutions & Services - Vigilance - Toxicology - Third Party Audit - Training Programs
共有8個產(chǎn)品
Vigilance
•Next-generation Safety Intelligence  for strategic and operational monitoring on (Bio)Pharmaco vigilance1 •National and International Vigilance subject to Regulatory Compliance •Certified Safety Audits and Activities (ISO 9001:2015)
Business & Communications
•Business development, sales strategy & operations •Marketing strategy & planning •Communication strategy, execution & support •EU Branding strategy, execution & support •Market analysis
Software Solutions & Services
Solutions Our solutions include a cloud-based and pre-validated QMS built for the life sciences, as well as eIFU services which enable IVD and MD manufacturers to digitalize paper Instructions For Use.  Services •Software validation (CSV) and
Lab Services
Chemical QC Laboratory •Routine analysis •Stability studies •Validation and projects QP batch release, QA oversight and RA services Microbiological Laboratory Monitoring services
Clinical
Clinical Development services: •Clinical Regulatory Strategy •Clinical Strategy •QMS •Medical writing We manage all aspects of clinical studies from early-phase clinical development to post-market surveillance.
Regulatory Affairs
Pharma, Medical Devices & IVD •Define the best Regulatory Strategy •Technical & scientific writing •CE Marking/ FDA Clearance / emerging markets / Global submissions •Compilation of technical files •Regulatory consult
Quality Assurance
Quality Management Systems •Tailored to customers' needs •GxP, medical devices or any other requirements •Business efficiency while living up to compliance standards Operations •Providing a full team, an expert, a co
Qualification & Validation
Qualification •Facilities •Utilities •Equipment Validation •Product •Cleaning •Sterilization •Processes •Analytical methods •Warehouse
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2006-2025 上海博華國際展覽有限公司版權(quán)所有(保留一切權(quán)利) 滬ICP備05034851號-57