SGS, the world’s leading testing, inspection and certification company, has set a new benchmark for third-party pharmaceutical testing laboratories in China following an outstanding inspection by the US Food and Drug Administration (FDA) of its Shanghai Health Science Laboratory.

For a third consecutive time, the facility was not issued a Form FDA 483 at the conclusion of the US FDA’s comprehensive inspection (Zero 483 inspectional observations), becoming the first third-party pharmaceutical testing laboratory in China to achieve this accolade.

In the global pharmaceutical market, international recognition of pharmaceutical quality systems is critical for companies to gain market access. As a globally recognized regulatory authority, the US FDA protects public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products and medical devices. To this end, GMP on-site inspections evaluate whether a company's operations quality management system meets international standards.

Over four days in September 2024, US FDA inspectors undertook a full-scope GMP compliance inspection of SGS’s Shanghai facility. Its focus included quality management, chemical and microbiological quality control laboratory management, sample management, personnel training, hardware/software system validation, method validation, documentation and records, electronic data management and data integrity.

Additionally, inspectors conducted on-site reviews of actual tests in physical, chemical, microbiological and sterile testing laboratories. 

Dr. Sandy Hao, Managing Director of SGS in China, said: “Our Shanghai Health Science Laboratory’s successful completion of the US FDA GMP on-site inspection with a zero 483 observations result is not only a testament to our long-standing commitment to excellent laboratory management practices but also a further consolidation of our authority and professionalism in the third-party pharmaceutical testing field.

“Our team continuously embraces SGS’s ‘Quality First’ mission to further enhance pharmaceutical brand reputation and customer confidence. With SGS support, Chinese pharmaceutical product manufacturers will continue to improve market reputation and customer trust, and readily access global markets. In partnership with our global pharmaceutical customers, we aim to drive the long-term, high-quality development of the healthcare industry in China.”

SGS provides analytical services spanning the entire drug development life cycle, including GMP-compliance QC testing, bioanalysis and clinical research, formulation development. We cover all segments such as chemical drugs, biopharmaceuticals, medical devices and pharmaceutical packaging materials.

SGS is committed to providing higher quality services to pharmaceutical companies in China and globally, helping products to be marketed efficiently and safely, and offering a solid guarantee for the health of patients worldwide.

About SGS 
We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories around the world.

SGS, the world’s leading testing, inspection and certification company, is pleased to offer a free expert-led webinar on plans by the European Union (EU) to ban bisphenol A (BPA) and other bisphenols in food contact materials.

The European Commission originally announced plans to ban BPA and other bisphenols in food contact materials in May 2023. On June 12, 2024, following a period of engagement with stakeholders, a draft final regulation was published. Adoption of this regulation is scheduled for November 2024, with enforcement by the end of the year.

During this complimentary webinar, SGS specialist Dr Torben Küchler will consider the history of bisphenols use, current discussions around toxicological assessment, the EU’s plan to ban bisphenols and its potential impact on food safety and the food contact materials industry.

The webinar will be of interest to quality managers in both food and food packaging manufacturers. It will be held on October 17, 2024, at 10.00 am EST.

Register now

About SGS 
We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories around the world.

Ace Therapeutics, a contract research organization engaged in cardiovascular disease research, is proud to announce the launch of its cardiovascular disease model development services, aiming to empower researchers and pharmaceutical companies with advanced tools and models to accelerate the study of cardiovascular diseases and drug discovery.

Cardiovascular disease (CVD) remains a leading cause of morbidity and mortality worldwide, underscoring the urgent need for innovative research and therapeutic solutions. Cardiovascular disease models are essential tools used in the research of heart-related conditions. These models can be biochemical, physiological, computational, or clinical, and they aim to simulate various aspects of cardiovascular health, disease progression, and responses to interventions. Recent years have witnessed the development of a series of disease models for cardiovascular disease research, such as cardiac organoid models and cardiomyocyte models, which greatly contribute to the basic research on the pathogenic mechanisms of various cardiovascular diseases and the development of new therapeutic methods.

Ace Therapeutics’ new suite of model development services is designed to provide customized, reliable, and reproducible preclinical models that closely mimic various cardiovascular conditions. In addition to a variety of experimental animals including mice, rats, rabbits, and monkeys, Ace Therapeutics can assist worldwide clients in constructing custom animal models using techniques such as environmental enrichment, gene editing, dietary modifications, or drug therapies. Moreover, the company can also provide researchers with cardiac organoid models and human induced pluripotent stem cell (hiPSC) models to support their research into the mechanisms of cardiovascular disease and facilitate the development of effective new drugs and cell therapies. Ultimately, these diverse models are developed to bridge the gap between laboratory research and clinical application for most cardiovascular diseases such as atherosclerosis, hypertension, thrombosis, heart failure, and cardiovascular infection.

Utilizing a range of specialized animal-specific hematology analyzers, biochemical analyzers, small animal PET/MRI imaging systems, and other instruments, Ace Therapeutics will conduct modeling, drug administration, sampling, and testing of physiological and biochemical indices in common laboratory animals for clients. These services are dedicated to advancing basic research, diagnostic method development, and drug development for cardiovascular diseases.

About Ace Therapeutics

Ace Therapeutics is a contract research service provider dedicated to providing a full range of research services for cardiovascular diseases. From disease model development to preclinical research support, Ace Therapeutics’ well-established research technology platforms enable its expert team to conduct research on a wide range of cardiovascular diseases, advancing the research and development in this field.

Hampshire, United Kingdom- September 20th, 2024– Artificial Intelligence (AI) has become a game-changer in numerous industries, and hospitality is no exception. From chatbots handling guest inquiries to predictive analytics optimizing pricing strategies, AI has permeated many facets of hotel operations. However, delivering true personalization—customized experiences that cater to individual guest preferences—has remained elusive for many. That is, until now. Introducing Allin, the revolutionary AI-powered guest personalization tool from Alliants, poised to redefine the guest experience across the hospitality industry.

While many AI solutions focus on operational efficiency, Allin by Alliants goes beyond the traditional uses of artificial intelligence. It addresses a major gap in the hospitality industry: creating meaningful, tailored experiences for each guest. By leveraging cutting-edge AI and machine learning algorithms, Allin can analyze guest data to provide personalized recommendations, streamline services, and even predict preferences before guests arrive.

“The future of hospitality lies in personalization, and Allin is a step toward truly understanding and anticipating guest needs,” said Tristan Gadsby, CEO of Alliants. “We’ve designed Allin to empower hotels to go beyond the one-size-fits-all model and deliver customized, unforgettable experiences.”

Allin integrates seamlessly with existing hotel management systems, gathering data from various touchpoints such as past bookings, guest interactions, and preferences. Using this data, the AI can tailor in-room amenities, suggest personalized dining options, and even recommend local experiences based on individual tastes. The more the system learns about a guest, the more refined its suggestions become.

For example, returning guests who prefer a particular room setting—whether it's a specific room temperature or a favorite pillow type—can have these preferences automatically applied upon check-in. Moreover, the AI can adjust services in real time, offering personalized concierge services via chat or voice interfaces throughout their stay.

By offering such advanced levels of personalization, Allin elevates the entire guest journey from pre-arrival to post-stay. This approach not only improves guest satisfaction but also drives brand loyalty, giving hotels a competitive edge in an increasingly crowded market.

Alliants is a leading provider of innovative software and services for the hospitality industry, specializing in enhancing guest experiences through technology. With a focus on AI-driven solutions, Alliants is committed to helping hotels deliver exceptional, personalized service. 

For more information on how Allin is transforming the hospitality industry, visit https://www.alliants.com/.