Solvias AG services

Solvias provides cGMP-compliant contract analytical services to help you ultimately provide safer products to consumers.

Solvias adopted the trend towards ever more highly potent and cytotoxic substances and is consequently offering virtually all analytical services for such compounds. Required protective measures such as:

Solvias offers characterization of new drug substances to meet the regulatory requirements for registration dossiers from physico-chemical parameter evaluation and preformulation up to the setting up of complete analytical test programs. Typical services include, but are not limited to:

Method Development : We have considerable experience in developing analytical methods for the complete range of our analytical portfolio, and for the entire lifecycle of a drug. Typical applications are:

Well-characterized reference substances make a crucial contribution to the accuracy of analyses in the pharmaceutical industry. Solvias provides a comprehensive service for reference substances of small molecules and biopharmaceuticals:

Quality Control analyses are routinely performed at Solvias according to GMP quality standards for

By combining fast and sensivtive analytical techniques with its experience and scientifc excellence, Solivas has the capabilities to support your pharmaceutical development process with efficient extractable and leachable testing for container closure systems (incl. inhalation devices and syringes), production process materials (incl. disposable systems), medical devices. Our services meet the requirements of the FDA, EMEA, ISO and are performed in accordance to the latest recommendation from consortias such as PQRI and BPSA.

Solvias offers a comprehensive service for microbiological testing of pharmaceuticals and pharmaceutical water. Many important microbiology methods have recently been harmonized between the USP, Ph. Eur., and JP. Solvias has adopted harmonized methods and can help with product-specific method adaptations and revalidations that may be necessary to comply with the new requirements.

Solvias provides comprehensive cGMP services at every stage of drug development. We can fully characterize any protein biopharmaceuticals for the Chemistry and Manufacturing Controls (CMC) section of Investigational New Drug applications (INDs), New Drug Applications (NDAs) and Biologic License Applications (BLAs).

At Solvias, we perform complete analytical development programs across our multidisciplinary laboratory infrastructure at our Kaiseraugst site. We understand that you need to progress rapidly and cost effectively at the early stage of drug development. Here, our extensive experience saves you time and we can normally apply generic methods to your protein. You can trust us to select promising analytical methods – and carry out development, validation and transfers – within the constraints of GMP and registration deadlines. Using our generic methods means that you stay one step ahead of the competition.