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Regulatory & Technical Department

SST’s Regulatory & Technical Department plays an essential role in the services we provide. The shifting of the burden of responsibility in regulatory and technical matters to SST is an enormous benefit to our customers.

We strive to provide both our suppliers and our customers with the most accurate and up-to-date information possible regarding current industry guidance and regulatory requirements. One of the most important functions of the Regulatory & Technical Department is to thoroughly evaluate and audit all current and potential SST suppliers to ensure their compliance with all Q7A, cGMP, ICH, FDA, DEA, TOSCA, OSHA and DOT regulations and standards. We also assist in preparing timely and accurate submissions of Drug Master Files (DMF), DMF Amendments and Post-Approval Change Supplements.

Arthur Fabian
SST works with our customers to ensure that their product specifications are matched by the supplier. A technical package that includes flow charts, samples, impurity profiles, stability data and specifications is used to facilitate development, scale-up and commercialization. Large quantities of documents are now scanned and distributed digitally, which expedites the technical process and facilitates easier searching and sharing of information (via email, etc.). SST also examines each manufacturing route for process patent and infringement issues, and assists with Customs and FDA Import Regulations.

Our Regulatory & Technical Department is dedicated to the highest professional standards – it is our goal to make all aspects of the regulatory and technical process as smooth as possible for our customers.

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SST has prided itself on its customer service for more than 50 years, bringing unparalleled reassurance and added value.
For custom synthesis, SST represents suppliers that work with your molecular and technological specifications.
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For more information on SST products and services, email us or call 844.476.8200.
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