Sai Life Sciences Ltd (SAI) is a leading contract development and manufacturing service provider that has been making significant contributions to the pharmaceutical and biotech industry since its establishment in 1999. With a strong focus on chemistry and an expanding range of services, SAI has become a trusted partner for companies seeking innovative solutions for drug discovery, development, and manufacturing.

Building Expertise in Chemistry

From its inception, SAI has prioritized the development of core capabilities in chemistry. These include synthetic chemistry, medicinal chemistry, process development, scale-up chemistry, analytical development, and both cGMP and non-GMP manufacturing. By honing these expertise areas, SAI has positioned itself as a reliable and versatile provider of comprehensive chemistry-based services to its clients.

Expanding into Formulation Development

Recognizing the growing demand for high-quality formulation development services, SAI has successfully expanded its service portfolio to encompass this crucial area. With a focus on enabling its partners to develop innovative medicines faster and at reduced costs, SAI’s formulation development services complement its existing chemistry capabilities, allowing for a seamless integration of drug discovery, development, and manufacturing processes.

A Partnership-driven Approach

SAI Life Sciences operates on a bedrock of partnership. The company collaborates closely with innovator pharma and biotech companies, aiming to accelerate the discovery, development, and manufacture of complex small molecules that contribute to a healthier tomorrow. The vision of SAI is to support its global innovator partners in bringing 25 new medicines to life by 2025, showcasing its commitment to driving meaningful advancements in the pharmaceutical industry.

Leadership and Expertise

The success of SAI’s partnerships is supported by a senior leadership team with extensive experience from various globally active companies. These seasoned professionals play a critical role in managing the success of partnerships and mentor the entire organization to become an ideal partner for clients. With a workforce of over 1,100, including a high percentage of skilled scientists, SAI ensures that its team possesses the expertise and knowledge necessary to deliver exceptional results.

Project Management Excellence

To maintain a consistent and effective process throughout customer projects, SAI places great emphasis on project management. A team of experienced delivery and project managers collaborates closely with development and operational groups to ensure timely delivery and meet project timelines. This dedicated focus on project management enables SAI to exceed customer expectations and drive successful outcomes across the entire project lifecycle.

State-of-the-Art Infrastructure

SAI has made strategic investments in state-of-the-art laboratory and manufacturing facilities located in Hyderabad and Bidar, India. The research infrastructure boasts approximately 200,000 square feet of process R&D lab space, providing a robust platform for innovation and scientific exploration. The two manufacturing sites offer over 180 cubic meters of capacity, enabling the production of key starting materials, cGMP intermediates, and APIs for both clinical trials and commercial drugs. These plants provide flexibility, accommodating a wide range of reaction capabilities and complex syntheses at multiple scales.

Commitment to Quality

Quality is a top priority for SAI, evident in its adherence to global regulatory and quality standards. The company follows guidelines such as ICH Q7, 21 CFR Part 210, 211, EU GMPs, and GMP guidelines from regulatory authorities including the USFDA, Mexican authorities, TGA, PMDA, TPD, and WHO. SAI’s commitment to quality is further reinforced by over 300 successful client and third-party audits. The harmonized quality standards across all SAI units are governed by corporate QA policies, ensuring consistency and reliability in every aspect of operations.

Customer-Centric Approach

SAI has fostered a culture of putting the customer first. With a clear focus on fast and timely delivery, the company is committed to exceeding environmental and safety regulations at all its facilities. By consistently delivering high-quality solutions and demonstrating a strong commitment to customer satisfaction, SAI Life Sciences has established itself as a reliable and trusted partner in the pharmaceutical and biotech industry.

Engr. Dex Marco Tiu Guibelondo, BS Pharm, RPh, BS CpE

Editor-in-Chief, PharmaFEATURES

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