Services Overview

If you have the product but don’t have the resources, we can help. Let us put our expertise to work for you. There is no need to let a business opportunity pass you by when partnering with Lyne can get you to market quickly, efficiently and with complete confidence.

In addition to expertise and service, you can count on us for total commitment to our business partnership. We’re flexible and responsible – able to adjust our operations to your needs and priorities. And we’re easily able to handle any changes that may arise. We think of our facilities as an extension of your operations and welcome your involvement. We’re as committed to your product’s success as you are.

Our dedicated staff of professionals can support your project from early stages of development up to and including commercial manufacturing.

Services available:

• Pre-Formulation and Formulation Development

• Process Development

• Process Scale-up

• Packaging Engineering and Development

• Clinical Supply Manufacturing

• Analytical Testing

• Methods Development and Validation

• Quality Assurance

• Small Scale Commercial Manufacturing

• Stability Studies

• Technology Transfer

• Process Calibration

• Regulatory Support

• Pilot Batches
   1 or 3 demonstration batches
   (1/10th of commercial batch size)

• Engineering Batches
   Scale-up to commercial size for evaluation
   prior to validation

• Commercial Services Validation
   Preparation of protocols and master documents
   First 3 commercial batches

• Commercial Batches
   Post-approval activities
   Full scale commercial activities

 

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