SERVICES

Process Development

  • Process codification
     

  • Process trending
     

  • Gap analysis
     

  • Process development planning

Development of a reproducible, cost effective, and cGMP compliant manufacturing process is critical for clinical and commercial success. Failure to plan for and execute a comprehensive, phase appropriate process development plan is common source of product failures in the Cell and Gene Therapy Industry. Our team helps you navigate this challenging path. Our most popular services include:

Process Codification: We help you define and describe your process for regulators and CMOs. Our standardized frameworks have proven track records of success in regulatory filings and technology transfers.

Process Evaluation: We compile the data from your scattered lab notebooks, study reports, and batch records into a comprehensive tracking-and-trending database. We evaluate this data using statistical analysis software to help you understand your process performance and trends as you never have before.

Process Development Planning: We help you to perform a gap analysis of your current process and develop a comprehensive product development roadmap for your product. We identify key items to be addressed at each stage of clinical development. We also assist you in developing your comparability plan to support those process changes.

Quality Systems

  • Strategy
     

  • Analysis
     

  • Gap Filling
     

  • Audits

We help you ensure stage-appropriate compliance systems so your program stays aligned with “Quality by Design” principals and ahead of the curve – without wasting resources, capital, or generating excessive bureaucracy.

QMS Design:
We help you develop a Quality Management System (QMS) that meets the unique needs of your program and stage of development.

Supplier Oversight:
We perform risk assessments and/or audits of critical raw material suppliers, contract manufacturers and analytical service providers to ensure their quality standards are aligned with your needs.

QMS Gap Assessment:
We analyze your existing QMS, identify any gaps, and provide stage appropriate and resource efficient solutions to address those gaps.

Manufacturing Support

  • CMO Selection
     

  • Technology
    Transfer

     

  • Person-in-plant

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Need more details? Contact us.

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