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Our Expertise

Manufacturing and CMC technical expertise to provide the highest quality support for your organization.
GMP Document Preparation

Exceptional technical writing to provide.

  • Standard Operating Procedures

  • Master Batch Records

  • Protocols

  • Reports

Validation

In depth technical knowledge of validation and generation of protocols and reports.

  • Equipment Validation

  • Process Validation

Lyophilization

Demonstrated lyophilization cycle troubleshooting, optimization, and development.

cGMP Manufacturing

Support for cGMP manufacturing

  • Technology Transfer

  • Executed Batch Record Review

  • Process Scale-up

  • Process Risk Analysis

  • Deviation Technical Review

  • Process Streamlining

  • Contract Site Management

  • On-Site Manufacturing Support (PIP)

 

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