以专家为专家服务

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理解跨学科需求是我们制药服务的核心。我们的专家专注于 溶出度测试,熟悉相关的各种挑战,包括监管规范和法规、不同的样品分析方法、开发稳健的方法、各种自动化仪器、 原料药表征、常规测试、稳定性测试等等。由于结果会受到原料药性质、制剂组成、生产工艺或生物制药性能预测等因素的影响,因此需要对这些不同领域有深入的了解才能充分发挥其潜力。

To take full advantage of its potential, one must have a solid understanding of the different domains that affect results, such as API characteristics, formulation composition, manufacturing process, and biopharmaceutical performance prediction.

Our heritage is in-vitro dissolution testing. Being the only Contract Research Organisation (CRO) with a dissolution testing speciality, our team has a track record of successfully determining the best approach for a wide range of products, including implants, semi-solids, tablets, APIs, and many more.

溶出度专家

体外溶出度测试已融入我们的基因。作为一家专注于溶出度测试的合同研究机构 (CRO),我们的团队拥有丰富的经验,能够为从原料药、片剂到植入剂、半固体制剂等众多产品找到最合适的测试方法。

Since 1973, SOTAX has focused on in-vitro dissolution testing; nevertheless, we offer much more than "just" dissolution-related pharma services.

跨越溶出度

自1973年以来,SOTAX一直专注于体外溶出度测试,但我们的制药服务范围远不止于溶出度相关服务。从原料药表征到稳定性测试,我们的团队拥有最先进的仪器设备,并精通各种分析技术,能够胜任不同类型的测试。


三个实验室,一个理念

SOTAX在欧洲、美国和印度设有三家实验室,所有实验室均采用同一套成熟的质量管理体系,确保在符合FDA检查和GMP认证的环境中提供一流的服务。无论您是需要方法开发方面的帮助,还是希望外包常规检测,我们的本地专家都将在您产品的整个生命周期中为您提供支持。

欧洲
法国

欧洲
法国

SPS Pharma Services Sàrl.
3 rue Chateaubriand
45071 Orleans Cedex 2, France
P Office +33 2 34 59 72 61
pharmaservices@sotax.com

This understanding encompasses both formulation and analytics, with specific competence in small and big compounds, oral and parenteral modes of administration, and immediate and modified release dosage forms.

美洲
美国

美洲
美国

SOTAX Corporation 
2400 Computer Drive
Westborough, MA 01581, USA
P Office +1 508 417 1112 
sotaxusa@sotax.com

Our team helps you find potential reasons and put solutions in place for certain issues that arise during the lifecycle of your goods, from troubleshooting to out-of-specification (OOS) investigations.

亚太地区
印度

亚太地区
印度

Ortiv-Q3 Research Pvt. Ltd.
Ratna Business Hub, B-202-207, 2nd Floor
Near Sanathal Circle, Sarkhej - Bavla Highway
Ahmedabad, Pin 382 210, India
P Office +91 76 7670 7801
info@ortiv.in

Together with state-of-the-art lab equipment, our completely cGMP certified environment and proven scientific know-how deliver first-rate services and 100% compliance. You can rely on our routine testing services because we are a US-FDA inspected facility and a certified pharmaceutical establishment with a qualified person.

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