QBD GROUP

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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

相關(guān)企業(yè)

蘇州海景醫(yī)藥科技有限公司

QBD GROUP相關(guān)資訊

甘草酸二胺：多領(lǐng)域應(yīng)用的制藥新星

防風(fēng)提取物：傳統(tǒng)中藥的現(xiàn)代制藥應(yīng)用

二苯基氧膦在制藥工業(yè)中的應(yīng)用研究

聯(lián)邦生物神經(jīng)肽Y2受體靶點獲FDA批準(zhǔn)臨床

業(yè)績虧損，股價卻連創(chuàng)新高，這三家藥企做對了什么？

華人學(xué)者一作兼通訊Cell論文：將光遺傳學(xué)用于藥物發(fā)現(xiàn)

QBD GROUP共有8個產(chǎn)品

Vigilance

簡介：•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

簡介：•Business development, sales strategy & operations •Marketing strategy & planning •Communication strategy, execution & support •EU Branding strategy, execution & support •Market analysis

Software Solutions & Services

簡介：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