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Method Development

Sharp Sterile is capable of designing methods to obtain desired analytical measurements with the appropriate characteristics.

During analytical method development the accuracy, precision, linearity, and specificity will be assessed as well as system suitability requirements. Our team will provide a development report detailing the laboratory work that was performed and expectations for performance of the method. A draft test method will also be provided.

Following method development, SSM can perform method qualification or validation, as appropriate for the development phase of the product.

Sterile Manufacturing Services
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“The people at Sharp are collaborative, responsive and always willing to accommodate our needs, and this is something to be admired. If they say they can do something, they will deliver no matter what – ultimately, their success is our success, and vice versa.”

Sr Quality Supplier Manager, Top 10 Pharmaceutical Company

“Sharp’s responsiveness and flexibility are truly gold standard. Their dedication to the core values of quality and service allows for a true partnership and success in getting our product to patients in need.

External Manufacturing, Top Mid-size Pharma Company

“Sharp is an exceptional partner in the packaging CMO space. They have a dedicated launch team which is unique and a huge benefit vs. having the project lead that handles commercial business also manage the launches. Launches can be very time consuming and they can focus on these activities vs. having to also manage the commercial side.

Top 10 Pharmaceutical Company

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