URSATEC
An Efficient and Trustworthy Laboratory Service Partner

One of the most important jobs in clinical laboratories is achieving and maintaining quality. They are unsafe for patients if the quality isn’t up to the desired standards. Poor quality scores can lead to mistrust between laboratories and end-users, jeopardizing evidence-based treatment and preventing successful collaborations between physicians and labs. Ensuring quality in a laboratory is a journey without a destination and extensively helping clients throughout this continual voyage in testing, validation, or verification of their product is URSATEC.

As a single service partner, URSATEC provides all the laboratory services a client needs to test, validate, or verify their product. The company cooperates closely with certified laboratories and is always available for clients as a central contact. Its laboratory services and those of its partners comply with strict international standards and ensure the successful approval and sale of a client’s product in national and international markets. Its partners also offer laboratory services ranging from the preclinical phase to the marketing authorization of a client’s products. The company’s services help clients develop new formulations or reformulation, develop and validate analytical methods, stability testing and storage, and testing of/on raw materials. Additionally, URSTEC’s analytical services include tests for sterility, yield/priming tests / residual volume tests / complete dosing on lifetime, rheological measurements, and testing for microbiological safety.

In addition to URSATEC’s in-depth technical know-how in product development can also support clients with development expertise gained from cooperation with scientists, physicians, and development experts. Together with its cooperation partners, URSATEC helps customers create new solutions for innovative pharmaceutical, medical and cosmetic products. The company supports clients as a central point of contact for new product development and takes over the entire project coordination.

URSATEC also has the appropriate connections for efficacy studies of a client’s product to deliver safe, tolerable, and at the same time highly effective products with proven efficacy that are key to their success.

All individual components of its patented systems are sterilized according to validated procedures to comply with relevant standards and regulations. The unique sterilization process with ethylene oxide has proven exceptionally safe, reliable, and gentle on the material. After completion of the sterilization cycle, the goods are degassed in special desorption chambers under validated conditions, ensuring that the residual amounts of ethylene oxide (EO), ethylene chlorohydrin (ECH), and ethylene glycol (EG) are below the limits specified in the applicable standards and guidelines. The company’s sterilization occurs exclusively at qualified and certified partner companies that are regularly audited.

Moreover, URSATEC can supply clients with sterile pharmaceutical, medical, and cosmetic finished products. From individual small batches to industrial campaign manufacturing of several million units per year. It has the appropriate solution for a client’s project that meets the high-quality requirements of sophisticated preservative-free products; URSATEC also engages qualified partner companies for the manufacturing. The company’s partners’ filling lines are set up in a Class A cleanroom environment designed by a team of scientists and engineers in consultation with industry and regulatory experts. Special design concepts and control systems for aseptic filling ensure complete protection of the preservative-free product against microbiological contamination. With such efficacious laboratory services, URSATEC is one of the most trusted and strong partners for clients, helping them in their journey to develop effective products.