Life Science & Healthcare

LFH Regulatory 是您值得信赖的合作伙伴，帮助您驾驭复杂的医疗器械和体外诊断法规。 我们公司由 Laura Friedl-Hirst 于 2019 年创立，现已迅速发展成为一支充满活力的团队，由九名充满激情的专业人士组成。我们与客户密切合作，使监管和合规过程尽可能无压力。 真正让LFH Regulation与众不同的是，我们致力于与客户建立牢固的长期关系。我们相信，协作和开放式沟通对于了解您的独特挑战和目标至关重要。通过与您的业务和产品密切合作，我们可以提供量身定制的解决方案，以消除医疗器械法规和体外诊断法规的压力。 我们引以为豪的是，我们能够简化监管流程，确保合规，同时将客户的负担降至最低。我们经验丰富的顾问对医疗器械和体外诊断法规的复杂性有深入的了解。我们利用这些专业知识来指导您应对复杂情况，从而节省您的时间、精力和压力。 在LFH Regulation，我们明白驾驭监管环境可能令人生畏。这就是为什么我们致力于为我们的客户提供尽可能顺畅的过程。我们与您密切合作，在每个阶段提供积极主动的指导、透明的沟通和个性化的关注。您的成功是我们的首要任务，我们致力于帮助您实现监管和业务目标。 我们为与客户建立的长期合作伙伴关系感到自豪。我们的成功在于我们交付成果、创造性思考和提供坚定不移的支持的能力。通过选择LFH Regulation，您可以期待一个专门的团队，他们超越自我，以确保您的合规之旅无压力和成功。  立即与我们合作，简化监管流程。    英国责任服务 https://lfhregulatory.co.uk/uk-responsible-person/

OMC Medical公司总部位于英国Horsham。OMC因其卓越的服务和透明度而深受客户信赖。 我们与世界各地的组织建立了合作伙伴关系，为我们的客户提供全球监管支持，包括注册，授权代表和市场准入。 我们专注于法规事务，支持全球法规（CE、FDA、UKCA、PMDA、 CDSCO、NMPA）。

ProImmune为临床前和临床免疫学研究提供独特的解决方案, 包括全面集成的抗原表征平台，以及使用最先进的 ELISpot 和流式细胞术技术跟踪抗原特异性免疫反应的产品和服务。Prolmmune在免疫系统领域成为领先者是因为他可以识别潜在表位（在免疫系统中可以识别的物质部分称为表位）并监测免疫系统对他们的反应。 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.

科瑞思特（Crystec）是一家英国高科技公司，掌握全球最先进的超临界流体结晶产业化平台技术(mSAS®)，一种高效、稳定，可放大的药物递送技术，并得到了药监部门的认可。该技术应用面广，适用于小分子化学药和大分子生物药，通过优化各种药物剂型（例如吸入,口服，鼻内，皮下，舌下），增强体内给药效率，提高临床疗效。公司创始人于九十年代中期在全球率先将超临界结晶技术应用于药物结晶和微粒设计领域，并带领团队发明了一系列工艺专利，成为全球公认的该领域领军人。科瑞思特建立了完整的超临界结晶技术（mSAS®)产业化设施和工艺开发能力，包括小试，中试到cGMP生产。同时，该公司根据临床需求及其技术优势，在某些重要领域开发了一系列自主创新产品管线，包括妇女健康，偏头痛，呼吸疾病，感染类等领域。科瑞思特的技术平台得到了中英两国政府的支持，公司先后获得英国科技部资助的高端生产技术链奖，创新部技术创新奖，和中英联合资助的中英牛顿基金奖，以及欧洲CPHI药物制剂和合同服务外包卓越奖。   科瑞思特（Crystec）与全球许多医药企业建立了合作，为他们提供优化的制剂解决方案，开发差异化产品。利用mSAS®平台技术的独特能力，开发更高质量（例如，提高药物稳定性和产品批次间一致性），更直接的给药靶点（例如，准确的局部给药），和更方便的使用（例如，吸入给药代替针剂），以提高临床疗效（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.

Actigen正在开发的GNR-055是一种用于治疗粘多糖累积症II型（MPS II）的新型脑穿透性依杜醛酸-2-硫酸酯酶替代疗法。由于MPS II的病程是可变的，并且随着儿童的逐渐发育而变得复杂，出生时看起来正常的儿童通常在2-4岁时开始表现出身体症状，包括呼吸和心脏功能障碍、认知缺陷、行为缺陷、神经系统受累和各种其他症状。GNR-055是专门设计的，通过抗体片段中的重组融合蛋白来解决体细胞和中枢神经系统缺陷，抗体片段可用于治疗MPS II。该抗体片段识别人胰岛素受体α-亚基的细胞外表位，并可通过血脑屏障运输。 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.

Woodley BioReg成立于2000年，致力于帮助制药、生物制药/生物仿制药、医疗保健和医疗器械公司开发和生产高质量的产品，为全球患者提供有效和安全的产品。Woodley BioReg与世界各地的客户合作，从世界上最大的制药公司到新兴的生物技术公司。我们利用在CMC、法规事务、GMP/QA和临床等各个方面的实践经验来加速药品的开发和批准。 Woodley BioReg利用其完善的cGMP认证流程和具有商业竞争力的监管批准策略，帮助其客户在全球范围内成功注册药物，包括在英国和欧盟。在自己的MHRA GMP许可下，Woodley BioReg使其国际客户能够将其产品出口到英国和欧盟进行分销。 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.   

Charles River旗下的Retrogenix细胞微阵列能够发现原代细胞表面受体以及潜在的脱靶细胞。经过10多年的扩展和完善，我们的细胞微阵列库现在有超过6500种蛋白质用于筛选，包括高于98%的怀孕8-10周的产前蛋白质。利用最大的市售质膜和人类细胞中表达的分泌蛋白，发现高质量、可开发的药物靶点和作用机制。该技术可用于多种生物制剂，包括抗体、蛋白质、小分子、病毒、CAR疗法和其他配体。结合抗体和细胞治疗开发平台的全面组合，Charles River可以加速您的药物开发管道，从候选药物选择到安全性评估等。 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.

Cizzle正在开发一种肺癌早筛的血液检测方法。该公司是约克大学的衍生公司，成立于2006年，基于Coverley教授及其同事的工作发现。它的概念验证原型测试是基于检测一种稳定的血浆生物标志物的能力，一种被称为CIZ1B的CIZ1变体。CIZ1是一种天然存在的参与DNA复制的细胞核蛋白，而靶向的CIZ1B变异与早期肺癌高度相关。 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. 

Fitabeo Therapeutics是一家临床阶段制药公司，专注于开发和商业化创新药物，为现有治疗方案不能满足其适应症的人群，提供更好的健康结果。Fitabeo利用创新科技开发药物，以期实现分散式患者护理并减少医疗服务开销。 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.

Artios Pharma 致力于通过基于癌细胞利用DNA损伤修复(DDR)反应来促进其生存，从而治愈癌症。我们的专业DcoDeR平台整合了Artios在DNA损伤生物学和药物发现方面的领导能力、专业知识和经验，系统地发现和开发针对DDR全过程的药物。Artios建立了大覆盖面的以DDR为重点的产品管线，旨在解决实体瘤适应症中还未实现解决方案的重点需求领域。Artios的主要产品是ATR抑制剂ART0380和Polθ抑制剂ART4215，这两种药物目前都处于临床1 / 2期，分别作为单一疗法和联合疗法开发。Artios与默克公司和诺华公司建立了世界级的战略合作伙伴关系，并与英国癌症研究中心、癌症研究所、荷兰癌症研究所和弗朗西斯·克里克研究所等一流机构开展了研究合作，共同开创了DDR药物研发的有效方法。 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.