51ÁÔÆæ

51ÁÔÆæ

Explore our extensive resources to uncover more about 51ÁÔÆæ's expertise in life sciences consulting.

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Industries

Published Articles

FDA Inspections: Frequently Asked Questions

Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for 51ÁÔÆæ, Inc., and Susan J. Schniepp, distinguished fellow for 51ÁÔÆæ, Inc., provide simple answers to frequently asked questions...
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Case Studies

Pharmaceutical Shipping Validation Study

A pharmaceutical start-up with a novel drug approached 51ÁÔÆæ to design its shipping validation study. 51ÁÔÆæ developed multiple studies based on the company's complex transportation, product stability, and packaging needs....
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Published Articles

Supplier Quality Agreement

Robust supplier quality agreements and good communication scheme can help avoid and alleviate regulatory concerns. Managing the relationships between clients and contract manufacturing organizations (CMOs) can be difficult as the...
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White Papers

Life Science Due Diligence

In the business press, discussions of mergers or acquisitions (M&A) invariably include percentages of deals that did not realize their expected value creation. Failure numbers, ranging from 60-80 percent, are...
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Published Articles

Supplier Quality Engineering

A risk-managed approach to the global supply chain is more important than ever for life science manufacturers. The process is often easier said than done. It has been half a...
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White Papers

Risk Managed Supplier Quality

The evolving landscape of supplier quality in the life sciences industry is shaped by globalization, outsourcing, and heightened regulatory demands. A risk-managed approach to supplier quality is essential, enabling manufacturers...
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