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These services allow you to leverage on the availability of and access to the expertise of an experienced staff to complement your in-house capabilities. Services include product and process troubleshooting, CMC section of a regulatory submission and batch record review, identifying equipment specifications, technology transfer, supporting process validation, and compliance auditing.
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Fulfilling part of the LTI mission, on-site in-house training on lyophilization is available. In this training program, the fundamental principles are coupled with practical aspects of lyophilization; principles and concepts presented are later used to discuss real world practical applications. These seminars have included participants in development, operations, engineering, technical services, quality, validation, and regulatory affairs. Customized training is also available covering other aspects of freeze drying, including compliance and validation.
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