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SynoloStats LLC

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Flemington, New Jersey, US

About SynoloStats LLC

We provide risk-based statistical solutions across the pharmaceutical product lifecycle. We are not only statisticians with expertise in methodologies applicable to pharmaceutical process development, validation, and commercial manufacturing; we also understand pharmaceutical processes and the regulatory and... Show more ยป

We provide risk-based statistical solutions across the pharmaceutical product lifecycle. We are not only statisticians with expertise in methodologies applicable to pharmaceutical process development, validation, and commercial manufacturing; we also understand pharmaceutical processes and the regulatory and business contexts in which the lifecycle is managed. We provide statistical guidance and analysis integrated into a holistic solution to a business need, and we have experience across a broad range of dosage forms and manufacturing platforms.

Specific examples of services/areas of expertise:

  • Quality by Design
  • Lifecycle Process Validation - Strategy and Execution, all stages
  • Design of Experiments (DOE)
  • Sampling Design
  • Acceptance Criteria/Specification Setting
  • Continuous Manufacturing
  • Analytical Similarity
  • Bayesian Methodology
  • Root Cause Analysis
  • Equivalence/Comparability
  • Training & Capability Building
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Our Services (3)


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Statistical Analysis

Price on request
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Statistical Study Design

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Computational Modeling

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