9/24/20 Leaderboard Pharma

Technical Services: Consulting and Training

Available from Lyophilization Technology, Inc.

Complementing LTI’s development sciences and clinical manufacturing, Technical Services include product and process troubleshooting, CMC section of a regulatory submission and batch record review, consulting on equipment specifications, process requirements, scale-up, supporting process validation, process excursions, technology transfer, and compliance auditing. 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.

• Equipment IQ / OQ
• Consulting and Auditing
• Troubleshooting
• Products / Processing Evaluation
• Equipment Specifications
• Process / Cycle Evaluation
• Quality / Compliance Support
• On-site / In-house Training

The fundamental principles and technology are coupled with practical aspects of lyophilization in the training program. Principles and concepts presented are later used to discuss real world practical applications. These training sessions 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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