Reghelps SRC在印度启动临床和监管服务,以支持医疗装置和全球的IVD开发商。 Reghelps SRC launches clinical and regulatory services in India to support medical device and IVD developers globally.

设在班加罗尔的一个合同研究组织Reghelps SRC在印度启动了专门的临床调查、市场后临床跟踪和IVD绩效评估服务。 Reghelps SRC, a Bangalore-based contract research organization, has launched specialized clinical investigation, post-market clinical follow-up, and IVD performance evaluation services in India. 该公司为医疗设备和IVD制造商提供端到端支持,以满足欧盟MDR、IVDR、美国林业发展局和印度CDSCO的监管要求。 The company offers end-to-end support for medical device and IVD manufacturers to meet regulatory requirements under EU MDR, IVDR, US FDA, and Indian CDSCO. 服务包括协议设计、地点选择、道德操守核准、数据管理和规章文件。 Services include protocol design, site selection, ethics approvals, data management, and regulatory documentation. 它与I3CGLOBAL合作,简化关于CE标识、UKCA、TGA和FDA的呈件。 It partners with I3CGLOBAL to streamline submissions for CE Marking, UKCA, TGA, and FDA. 具有监管事务和临床战略专门知识的Reghelps SRC旨在通过提供符合要求的高质量研究、更快的周转和强有力的数据完整性,增强印度作为全球临床研究中心的作用。 With expertise in regulatory affairs and clinical strategy, Reghelps SRC aims to enhance India’s role as a global clinical research hub by delivering compliant, high-quality studies with faster turnaround and strong data integrity.