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LFH監(jiān)管有限公司

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東北部

LFH Regulatory 是您值得信賴的合作伙伴，幫助您駕馭復(fù)雜的醫(yī)療器械和體外診斷法規(guī)。 我們公司由 Laura Friedl-Hirst 于 2019 年創(chuàng)立，現(xiàn)已迅速發(fā)展成為一支充滿活力的團(tuán)隊(duì)，由九名充滿激情的專業(yè)人士組成。我們與客戶密切合作，使監(jiān)管和合規(guī)過程盡可能無壓力。 真正讓LFH Regulation與眾不同的是，我們致力于與客戶建立牢固的長(zhǎng)期關(guān)系。我們相信，協(xié)作和開放式溝通對(duì)于了解您的獨(dú)特挑戰(zhàn)和目標(biāo)至關(guān)重要。通過與您的業(yè)務(wù)和產(chǎn)品密切合作，我們可以提供量身定制的解決方案，以消除醫(yī)療器械法規(guī)和體外診斷法規(guī)的壓力。 我們引以為豪的是，我們能夠簡(jiǎn)化監(jiān)管流程，確保合規(guī)，同時(shí)將客戶的負(fù)擔(dān)降至最低。我們經(jīng)驗(yàn)豐富的顧問對(duì)醫(yī)療器械和體外診斷法規(guī)的復(fù)雜性有深入的了解。我們利用這些專業(yè)知識(shí)來指導(dǎo)您應(yīng)對(duì)復(fù)雜情況，從而節(jié)省您的時(shí)間、精力和壓力。 在LFH Regulation，我們明白駕馭監(jiān)管環(huán)境可能令人生畏。這就是為什么我們致力于為我們的客戶提供盡可能順暢的過程。我們與您密切合作，在每個(gè)階段提供積極主動(dòng)的指導(dǎo)、透明的溝通和個(gè)性化的關(guān)注。您的成功是我們的首要任務(wù)，我們致力于幫助您實(shí)現(xiàn)監(jiān)管和業(yè)務(wù)目標(biāo)。 我們?yōu)榕c客戶建立的長(zhǎng)期合作伙伴關(guān)系感到自豪。我們的成功在于我們交付成果、創(chuàng)造性思考和提供堅(jiān)定不移的支持的能力。通過選擇LFH Regulation，您可以期待一個(gè)專門的團(tuán)隊(duì)，他們超越自我，以確保您的合規(guī)之旅無壓力和成功。  立即與我們合作，簡(jiǎn)化監(jiān)管流程。    英國(guó)責(zé)任服務(wù) https://lfhregulatory.co.uk/uk-responsible-person/

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OMC Medical

生命科學(xué)與醫(yī)療健康

培訓(xùn)機(jī)構(gòu) B2B

西南部

OMC Medical公司總部位于英國(guó)Horsham。OMC因其卓越的服務(wù)和透明度而深受客戶信賴。 我們與世界各地的組織建立了合作伙伴關(guān)系，為我們的客戶提供全球監(jiān)管支持，包括注冊(cè)，授權(quán)代表和市場(chǎng)準(zhǔn)入。 我們專注于法規(guī)事務(wù)，支持全球法規(guī)（CE、FDA、UKCA、PMDA、 CDSCO、NMPA）。

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ProImmune

生命科學(xué)與醫(yī)療健康

研究與開發(fā)

ProImmune為臨床前和臨床免疫學(xué)研究提供獨(dú)特的解決方案, 包括全面集成的抗原表征平臺(tái)，以及使用最先進(jìn)的 ELISpot 和流式細(xì)胞術(shù)技術(shù)跟蹤抗原特異性免疫反應(yīng)的產(chǎn)品和服務(wù)。Prolmmune在免疫系統(tǒng)領(lǐng)域成為領(lǐng)先者是因?yàn)樗梢宰R(shí)別潛在表位（在免疫系統(tǒng)中可以識(shí)別的物質(zhì)部分稱為表位）并監(jiān)測(cè)免疫系統(tǒng)對(duì)他們的反應(yīng)。 ProImmune offer unique solutions for preclinical and clinical immunology research, including a comprehensive and integrated antigen characterization platform, and products and services for tracking antigen-specific immune responses with state-of-the-art ELISpot and flow cytometry techniques. Portions of substances that the immune system can recognise are called epitopes, and identifying potential epitopes and monitoring the immune response to them is where ProImmune has become a world leader.

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Crystec Pharma

生命科學(xué)與醫(yī)療健康

研究與開發(fā)

科瑞思特（Crystec）是一家英國(guó)高科技公司，掌握全球最先進(jìn)的超臨界流體結(jié)晶產(chǎn)業(yè)化平臺(tái)技術(shù)(mSAS?)，一種高效、穩(wěn)定，可放大的藥物遞送技術(shù)，并得到了藥監(jiān)部門的認(rèn)可。該技術(shù)應(yīng)用面廣，適用于小分子化學(xué)藥和大分子生物藥，通過優(yōu)化各種藥物劑型（例如吸入,口服，鼻內(nèi)，皮下，舌下），增強(qiáng)體內(nèi)給藥效率，提高臨床療效。公司創(chuàng)始人于九十年代中期在全球率先將超臨界結(jié)晶技術(shù)應(yīng)用于藥物結(jié)晶和微粒設(shè)計(jì)領(lǐng)域，并帶領(lǐng)團(tuán)隊(duì)發(fā)明了一系列工藝專利，成為全球公認(rèn)的該領(lǐng)域領(lǐng)軍人?？迫鹚继亟⒘送暾某R界結(jié)晶技術(shù)（mSAS?)產(chǎn)業(yè)化設(shè)施和工藝開發(fā)能力，包括小試，中試到cGMP生產(chǎn)。同時(shí)，該公司根據(jù)臨床需求及其技術(shù)優(yōu)勢(shì)，在某些重要領(lǐng)域開發(fā)了一系列自主創(chuàng)新產(chǎn)品管線，包括婦女健康，偏頭痛，呼吸疾病，感染類等領(lǐng)域。科瑞思特的技術(shù)平臺(tái)得到了中英兩國(guó)政府的支持，公司先后獲得英國(guó)科技部資助的高端生產(chǎn)技術(shù)鏈獎(jiǎng)，創(chuàng)新部技術(shù)創(chuàng)新獎(jiǎng)，和中英聯(lián)合資助的中英牛頓基金獎(jiǎng)，以及歐洲CPHI藥物制劑和合同服務(wù)外包卓越獎(jiǎng)。   科瑞思特（Crystec）與全球許多醫(yī)藥企業(yè)建立了合作，為他們提供優(yōu)化的制劑解決方案，開發(fā)差異化產(chǎn)品。利用mSAS?平臺(tái)技術(shù)的獨(dú)特能力，開發(fā)更高質(zhì)量（例如，提高藥物穩(wěn)定性和產(chǎn)品批次間一致性），更直接的給藥靶點(diǎn)（例如，準(zhǔn)確的局部給藥），和更方便的使用（例如，吸入給藥代替針劑），以提高臨床療效（例如，提高生物利用度和快速起效）,造福患者。 CrystecPharma is a crystal and particle engineering company applying proprietary modified supercritical fluid (SCF) technologies to improve the performance of medicines. The technology enables drug molecules to be crystallised in new forms and novel particles to be manufactured in ways that greatly enhance their therapeutic performance. Crystec has an enabling platform which can be applied to small and large molecules, to optimise a range of medicine dosage forms (e.g. oral, inhaled, intranasal, subcutaneous, sublingual). Crystec works with the global pharmaceutical and health care industry to solve drug particle formation, formulation and process challenges. They are also developing their own innovative therapies in important areas of unmet clinical need, including women’s health, urology and treating respiratory disease. Crystec’s proprietary ‘mSAS?’ (modified Supercritical Anti-Solvent) drug delivery technology is enabled by a highly efficient, stable and fully scalable manufacturing process and is approved by regulatory authorities. This award winning mSAS? platform creates unique opportunities to improve medicines in ways that can transform the quality of life for many patients. The Crystec team is multi-disciplinary with extensive experience in pharmaceutical development. The team have pioneered the application of SCF to pharmaceuticals and consists of acknowledged leaders in relevant fields of science, drug delivery, engineering, scale-up, manufacturing and medicine, underpinned by senior-level pharmaceutical industry and licensing experience.

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Actigen正在開發(fā)的GNR-055是一種用于治療粘多糖累積癥II型（MPS II）的新型腦穿透性依杜醛酸-2-硫酸酯酶替代療法。由于MPS II的病程是可變的，并且隨著兒童的逐漸發(fā)育而變得復(fù)雜，出生時(shí)看起來正常的兒童通常在2-4歲時(shí)開始表現(xiàn)出身體癥狀，包括呼吸和心臟功能障礙、認(rèn)知缺陷、行為缺陷、神經(jīng)系統(tǒng)受累和各種其他癥狀。GNR-055是專門設(shè)計(jì)的，通過抗體片段中的重組融合蛋白來解決體細(xì)胞和中樞神經(jīng)系統(tǒng)缺陷，抗體片段可用于治療MPS II。該抗體片段識(shí)別人胰島素受體α-亞基的細(xì)胞外表位，并可通過血腦屏障運(yùn)輸。 Actigen, a privately funded UK company, is currently developing GNR-055, A novel brain-penetrating iduronate-2-sulfatase enzyme replacement therapy for treatment of MPS II. Because the course of MPS II is variable and complicated by the gradual development of the child, children who appear normal at birth typically begin to exhibit physical symptoms, including respiratory and cardiac dysfunction, cognitive deficits, behavioral deficits, neurological involvement, and a variety of other symptoms by the age of 2-4 years.GNR-055 is specifically designed to address both the somatic and CNS deficits through a recombinant fusion protein in the antibody fragment, an antibody fragment that can be used to treat MPS II. recombinant fusion protein, the antibody fragment recognizes the extracellular epitope of the α-subunit of the human insulin receptor and can be transported across the blood-brain barrier.

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Woodley BioReg

生命科學(xué)與醫(yī)療健康

研究與開發(fā)

Woodley BioReg成立于2000年，致力于幫助制藥、生物制藥/生物仿制藥、醫(yī)療保健和醫(yī)療器械公司開發(fā)和生產(chǎn)高質(zhì)量的產(chǎn)品，為全球患者提供有效和安全的產(chǎn)品。Woodley BioReg與世界各地的客戶合作，從世界上最大的制藥公司到新興的生物技術(shù)公司。我們利用在CMC、法規(guī)事務(wù)、GMP/QA和臨床等各個(gè)方面的實(shí)踐經(jīng)驗(yàn)來加速藥品的開發(fā)和批準(zhǔn)。 Woodley BioReg利用其完善的cGMP認(rèn)證流程和具有商業(yè)競(jìng)爭(zhēng)力的監(jiān)管批準(zhǔn)策略，幫助其客戶在全球范圍內(nèi)成功注冊(cè)藥物，包括在英國(guó)和歐盟。在自己的MHRA GMP許可下，Woodley BioReg使其國(guó)際客戶能夠?qū)⑵洚a(chǎn)品出口到英國(guó)和歐盟進(jìn)行分銷。 Founded in 2000, Woodley BioReg is dedicated to helping pharmaceutical, biopharmaceutical /biosimilar, healthcare and medical device companies develop and manufacture high quality products that are effective and safe for patients worldwide. Woodley BioReg works with a wide range of clients around the world, from the world's largest pharmaceutical companies to start-up biotechnology organisations.  We use our hands-on experience in all aspects of CMC, Regulatory Affairs, GMP/QA and Clinical to accelerate the development and approval of medicinal products. Woodley BioReg helps its clients to successfully register drugs worldwide including in the UK and EU using its well-established process for cGMP certification and commercially competitive regulatory approval strategies.  Under its own MHRA GMP licence, Woodley BioReg enables its international clients to export their products to the UK and EU for distribution.   

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Charles River

生命科學(xué)與醫(yī)療健康

研究與開發(fā)

Charles River旗下的Retrogenix細(xì)胞微陣列能夠發(fā)現(xiàn)原代細(xì)胞表面受體以及潛在的脫靶細(xì)胞。經(jīng)過10多年的擴(kuò)展和完善，我們的細(xì)胞微陣列庫(kù)現(xiàn)在有超過6500種蛋白質(zhì)用于篩選，包括高于98%的懷孕8-10周的產(chǎn)前蛋白質(zhì)。利用最大的市售質(zhì)膜和人類細(xì)胞中表達(dá)的分泌蛋白，發(fā)現(xiàn)高質(zhì)量、可開發(fā)的藥物靶點(diǎn)和作用機(jī)制。該技術(shù)可用于多種生物制劑，包括抗體、蛋白質(zhì)、小分子、病毒、CAR療法和其他配體。結(jié)合抗體和細(xì)胞治療開發(fā)平臺(tái)的全面組合，Charles River可以加速您的藥物開發(fā)管道，從候選藥物選擇到安全性評(píng)估等。 The Retrogenix Cell Microarray enables the discovery of primary cell surface receptors as well as potential off-targets. With over 10 years of expansion and refinement, our cell microarray libraries now have over 6,500 proteins for screening, including >98% of prenatal proteins present at 8-10 weeks of pregnancy. Discover high quality, exploitable drug targets and mechanisms of action using the largest commercially available set of plasma membrane and secreted proteins expressed in human cells. The technology can be used with a wide variety of biologics including antibodies, proteins, small molecules, viruses, CAR therapeutics, and other ligands. Together with an exhaustive portfolio for antibody and cellular therapeutic development platforms, Charles River can accelerate your drug development pipelines from candidate selection to safety assessment and beyond.

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Cizzle正在開發(fā)一種肺癌早篩的血液檢測(cè)方法。該公司是約克大學(xué)的衍生公司，成立于2006年，基于Coverley教授及其同事的工作發(fā)現(xiàn)。它的概念驗(yàn)證原型測(cè)試是基于檢測(cè)一種穩(wěn)定的血漿生物標(biāo)志物的能力，一種被稱為CIZ1B的CIZ1變體。CIZ1是一種天然存在的參與DNA復(fù)制的細(xì)胞核蛋白，而靶向的CIZ1B變異與早期肺癌高度相關(guān)。 Cizzle Biotechnology is developing a blood test for the early detection of lung cancer. The Company is a spin- out from the University of York, founded in 2006, around the work of Professor Coverley and colleagues. Its proof-of-concept prototype test is based on the ability to detect a stable plasma biomarker, a variant of CIZ1 known as CIZ1B. CIZ1 is a naturally occurring cell nuclear protein involved in DNA replication, and the targeted CIZ1B variant is highly correlated with early-stage lung cancer. 

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Fitabeo Therapeutics

生命科學(xué)與醫(yī)療健康

研究與開發(fā)

Fitabeo Therapeutics是一家臨床階段制藥公司，專注于開發(fā)和商業(yè)化創(chuàng)新藥物，為現(xiàn)有治療方案不能滿足其適應(yīng)癥的人群，提供更好的健康結(jié)果。Fitabeo利用創(chuàng)新科技開發(fā)藥物，以期實(shí)現(xiàn)分散式患者護(hù)理并減少醫(yī)療服務(wù)開銷。 Fitabeo Therapeutics is a clinical-stage pharmaceutical company that develops and commercialises innovative medicines focusing on indications where existing treatments are inadequate for the target population to provide better health outcomes. It deploys innovative technologies to develop medicines that are expected to enable decentralised patient care and provide significant healthcare savings.

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Artios Pharma

生命科學(xué)與醫(yī)療健康

研究與開發(fā)

Artios Pharma 致力于通過基于癌細(xì)胞利用DNA損傷修復(fù)(DDR)反應(yīng)來促進(jìn)其生存，從而治愈癌癥。我們的專業(yè)DcoDeR平臺(tái)整合了Artios在DNA損傷生物學(xué)和藥物發(fā)現(xiàn)方面的領(lǐng)導(dǎo)能力、專業(yè)知識(shí)和經(jīng)驗(yàn)，系統(tǒng)地發(fā)現(xiàn)和開發(fā)針對(duì)DDR全過程的藥物。Artios建立了大覆蓋面的以DDR為重點(diǎn)的產(chǎn)品管線，旨在解決實(shí)體瘤適應(yīng)癥中還未實(shí)現(xiàn)解決方案的重點(diǎn)需求領(lǐng)域。Artios的主要產(chǎn)品是ATR抑制劑ART0380和Polθ抑制劑ART4215，這兩種藥物目前都處于臨床1 / 2期，分別作為單一療法和聯(lián)合療法開發(fā)。Artios與默克公司和諾華公司建立了世界級(jí)的戰(zhàn)略合作伙伴關(guān)系，并與英國(guó)癌癥研究中心、癌癥研究所、荷蘭癌癥研究所和弗朗西斯·克里克研究所等一流機(jī)構(gòu)開展了研究合作，共同開創(chuàng)了DDR藥物研發(fā)的有效方法。 Artios Pharma is on a mission to kill cancer by exploiting DNA damage repair (DDR) responses that are leveraged by cancer cells to promote their survival. Its specialized DcoDeR platform integrates Artios’ leadership capabilities, expertise and experience in DNA damage biology and drug discovery to systematically discover and develop medicines targeting the totality of the DDR. Artios has built an extensive DDR focused pipeline designed to address areas of high unmet needs across solid tumour indications. Its lead programs are our ATR inhibitor, ART0380, and our Polθ inhibitor, ART4215, both currently in Phase 1 / 2 develop as monotherapy and with combination treatments. Together with its world-class strategic partnerships with Merck KGaA and Novartis, and research collaborations with premiere institutions like Cancer Research UK, The Institute of Cancer Research, The Netherlands Cancer Institute, and the Crick Institute we are pioneering validated approaches to DDR drug discovery.

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