澎立檢測是獨立的第三方醫(yī)療器械檢測臨床前動物實驗一站式服務(wù)平臺，是全國首家醫(yī)療器械領(lǐng)域獲得CNAS認證的第三方大動物實驗中心。技術(shù)團隊主要實驗人員均具有10年以上醫(yī)療器械行業(yè)工作經(jīng)驗。現(xiàn)有設(shè)備：通用?IGS330?DSA，飛利浦?EPIQ7C?四維超聲，西門子心腔內(nèi)超聲ICE；OCT系統(tǒng)；骨科小型C臂機等；擁有超過4500平方米的標準動物飼養(yǎng)區(qū)：配備多功能手術(shù)區(qū)，可同時開展介入手術(shù)，無菌植入手術(shù)及急性培訓(xùn)手術(shù)。服務(wù)包括：動物實驗方案設(shè)計與法規(guī)咨詢、產(chǎn)品可行性分析與驗證設(shè)計、臨床前動物實驗測試與研究、病理學(xué)及藥代動力學(xué)分析研究、臨床申報和注冊申報支持、醫(yī)師培訓(xùn)服務(wù)、上市推廣支持服務(wù)。
PharmaLegacy?Diagnostic?Laboratories?(Shanghai)?Co.,?Ltd.?is?a?pre-clinical?large?animal?experiment?facility.?PharmaLegacy?Diagnostics?focus?on?high-risk?medical?device?testing?in?preclinical?area,?and?provide?one-stop?services.?The?operation?follows?international?GLP?regulations/guidelines,?AAALAC?standards.?PharmaLegacy?Diagnostics?has?filed?China?National?Accreditation?Service?for?Conformity?Assessment?and?got?the?certification,?No.:?CNAS?LA0011..?
PharmaLegacy?Diagnostics?focus?on?the?preclinical?animal?tests,?including?study?protocol?design,?related?regulatory?consultation,?animal?experiment?tests,?pathology?/pharmacokinetic?analysis,?and?pre-market?support.?Scopes?cover?cardiovascular,?intracranial,?osseous/dental?degradable?implants,?active?implantable?medical?devices,?and?drug?delivery?systems,?etc.