Services 2018-03-21T14:19:57+00:00

Fully vetted. Fully integrated. Fully prepared from start to finish.

LSNE has what it takes to manage your development, formulation and lyophilization projects with minimal complications and maximum efficiency.

With our integrated facilities, we can handle development and commercialization from start to finish. Which means fewer vendors, minimal tech transfer, and less chance for unforeseen delays.

Of course, we also have the flexibility and expertise to tackle specific parts of the process with an equal amount of attention (on our part) and ease (on yours).

Take a look.

Analytical Method Development

Analytical Method Transfer

Analytical Method Verification / Validation

Analytical Method Optimization

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Solubility Studies

Formulation Development

R&D Stability

Lyo Cycle Development

Thermal Characterization

Scale-up

Engineering Support

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Tech Transfer

Process Development / Optimization

Batch Record / Documentation

Incoming Product Review

Engineering

Formulation / Filtration

Fill / Finish

Lyophilization

Testing

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Tech Transfer

Batch Record / Documentation

Incoming Product Review

Formulation / Filtration

Filling (vials and trays)

Lyophilization

Harvest / Packaging

Testing

Release

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Tech Transfer

Batch Record / Documentation

Incoming Product Review

Engineering Run

Formulation

Filling

Lyophilization

Crosslinking

Packaging

Release

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In Process Testing

Final Product Testing

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Photostability

Final Product Stability

Stability Report

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DMF Reference

CMC Writing

Regulatory Path Support

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Ink Jetting

Vial Labeling

Kitting

Storage

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Analytical method development / transfer

Process development

Scale-up Registration batches / PV batches

ICH Stability

Access to Type V DMF reviewed and approved by the FDA

Regulatory writing

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