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:
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