For Experts.
By Experts.
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Pharma Services
The unique application know-how and experience of the SOTAX Pharma Services team helps pharmaceutical companies worldwide in overcoming the various challenges associated with dissolution and release testing from pharmaceutical dosage forms. Specialized in in vitro dissolution testing, our team has a proven track record of finding the most suitable method for products ranging from APIs and tablets to implants, semi solids, and many more. Set in a US FDA-inspected facility, with a cGMP-compliant environment with strict quality management processes, the scientific expertise of our staff paired with state-of-the-art instrumentation ensures best in class services and ease of regulatory compliance for our customers.
Sample Management.
Sample Management.
Keeping your samples under controlled conditions at all times is the prerequisite for reliable results. Strict handling processes executed by trained lab professionals using state-of-the-art equipment ensure maximum repeatability and prevent external factors from influencing your test results.
Testing & Analysis.
Testing & Analysis.
We are experts at what we do. Our pharmaceutical professionals are experienced in mastering all analytical techniques and our laboratories are equipped with instrumentation from different manufacturers – allowing our team to perform a wide range of tests and analytical analysis.
Compliant Documentation.
Compliant Documentation.
Everything we do is about compliance – from test execution to documentation. Whether your service includes simple test records or requires comprehensive studies for filing with regulatory authorities, you can expect our documentation to meet all applicable international standards.
Experts
for Experts.
Experts
for Experts.
Our global team of experts helps pharma companies worldwide in overcoming the various challenges associated with developing & testing pharmaceutical dosage forms. Set in a US FDA-inspected facility with cGMP compliant processes, the scientific expertise of our staff paired with state-of-the art instrumentation ensures best in class service.
R&D Services –
For your formulation.
R&D Services –
For your formulation.
We offer unique knowledge based on decades of experience in developing methods for pharmaceutical products. Such knowledge is related to both analytics as well as formulation and includes expertise for small and large molecules, immediate or modified release dosage forms, oral and parenteral routes of administration.
Routine Testing
Services (GMP).
Routine Testing
Services (GMP).
Are you looking for routine GMP testing including associated services in a US FDA-inspected facility? Our fully cGMP-compliant environment and proven scientific knowhow in combination with modern lab equipment provide first class services and 100% compliance.
Support Services –
Need help?
Support Services –
Need help?
Whether you need to identify possible causes and solutions for your specific problem throughout the product lifecycle or need to review analytical and clinical data from a failed bioequivalence for troubleshooting in order to de-risk the next steps of development, our unique knowledge based on decades of experience and interactions with health agencies can provide valuable help for your specific problem.
Three Labs.
One Philosophy.
Three Labs.
One Philosophy.
Are you looking for a certified pharmaceutical establishment to perform release testing for the European Union (EU), the United States (USA) or Asia-Pacific (IN)? Do you need assistance with developing your analytical method – or would you like to avoid costly human studies by performing in-vitro characterization and in-vitro bioequivalence studies? SOTAX operates dedicated Pharma Services laboratories on three continents with local experts covering different disciplines for your individual challenge.
What is your
Application?
What is your
Application?
SOTAX Pharma Services provides clients with knowledge, research and testing for all types of dosage forms. From solid oral products like tablets and capsules to many other dosage forms such as microspheres, liposomes, injectable suspensions, ophthalmic suspensions, coated medical devices (e.g. stents), creams, gels and implants.
