公司简介
Company Profile
上海和加欢医药科技有限公司成立于2018年,位于闵行区中科园。专注于国内外药品和其他健康产品的法规合规性,提供中国法规事务服务、药品注册咨询、GMP合规性咨询等专业服务。
H&H Pharmaceutical Co., Ltd was established in 2018 and is located in Zhongke Park, Minhang District. Focusing on regulatory compliance for domestic and international pharmaceuticals and health products, providing Chinese regulatory affairs services, drug registration consulting, GMP compliance consulting and other professional services.
在中国法规事务服务方面,能够精准解读国内复杂多变的医药法规政策,为企业在药品研发、生产、销售等各个环节提供合规指导,助力企业规避潜在的法规风险。
In terms of regulatory affairs services, we can accurately interpret complex and ever-changing domestic pharmaceutical regulations and policies, providing compliance guidance for enterprises in various stages of drug research and development, production, and sales, helping enterprises avoid potential risks.
在药品注册咨询方面,团队凭借丰富的经验和专业知识,为客户制定科学合理的注册策略,从资料准备到申报流程,全程提供细致且高效的服务,大大提高药品注册的成功率和效率。
The drug registration consulting team, with rich experience, formulates scientific and reasonable registration strategies for clients, providing meticulous and efficient services throughout the entire process from data preparation to declaration procedures, improving registration success rate and efficiency.
在 GMP 合规性咨询领域,和加欢深入企业生产一线,依据 GMP 标准对企业的生产设施、工艺流程、人员管理等进行全面评估,提出针对性的改进方案,帮助企业建立起符合规范的质量管理体系,确保产品质量稳定可靠。
In the field of GMP compliance consulting, we go deep into the enterprise's production frontline, conduct comprehensive evaluations of production facilities, process flows, personnel management, etc. in accordance with GMP standards, propose targeted improvement plans, and help establish standardized quality management systems.