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QBD GROUP

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簡(jiǎn)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

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蘇州海景醫藥科技有限公司

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QBD GROUP共有8個(gè)產(chǎn)品

Vigilance

簡(jiǎn)介：•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

簡(jiǎn)介：•Business development, sales strategy & operations •Marketing strategy & planning •Communication strategy, execution & support •EU Branding strategy, execution & support •Market analysis

Software Solutions & Services

簡(jiǎn)介：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

簡(jiǎn)介：Chemical QC Laboratory •Routine analysis •Stability studies •Validation and projects QP batch release, QA oversight and RA services Microbiological Laboratory Monitoring services

Clinical

簡(jiǎn)介：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

簡(jiǎn)介：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

簡(jiǎn)介：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