Product/Service

Logistics Audit/Assessment & Engineering Solution Services

Source: LoJack SCI, Inc.

Modality Solutions provides services such as: cGMP readiness assessments, product characterization and stability studies for distribution, controlled-environment logistics process validation, quality management systems and change control, and thermal packaging design and qualification.

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Audits/Assessments
GDP Audit
Perform an audit of an organization (usually a pharma/biotech company) versus current Good Distribution Practices in the biopharma industry. Prepare a report with observations, root cause failure analysis, and mitigation strategies for the observations.

GMP Audit
Perform an audit of an organization (usually supplier of pharma/biotech company) versus current Good Manufacturing Practices in the biopharma industry. Prepare a report with observations, root cause failure analysis, and mitigation strategies for the observations.

  • Cargo Security Audit
  • C-TPAT (Customs Trade Partners Against Terrorism) Audit
  • Cold Chain Risk Assessment
  • Environmental Assessment

Engineering

  • Implement improvements in existing integrated cold chain.
  • Create new fully integrated cold chain for new products or existing products in new markets.Assist and/or lead qualification of new packaging, monitoring, shipping for an existing cold chain.
  • Conduct comparative studies of competing technologies to assist in selection process.
  • Conduct transportation simulation tests of biopharma products to assist in the development of transport-stable formulations.
  • Write protocols in support of any or all of the above, but especially for qualification of new technologies in existing cold chains.

 

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