ÐÓ°ÉÂÛ̳

Resources

Explore our extensive resources to uncover more about ÐÓ°ÉÂÛ̳'s expertise in life sciences consulting.

Content Type

Segment

Industries

Podcasts

Warning Letter Remediation

In this episode of ÐÓ°ÉÂÛ̳ Radio, host, Brandon Miller, and ÐÓ°ÉÂÛ̳® Executive VP of Pharmaceuticals, Steven Lynn, go over how ÐÓ°ÉÂÛ̳ helped an international company perform a gap...
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Podcasts

Quality Management System

In this episode of ÐÓ°ÉÂÛ̳ Radio, guest host Dean Coston and Susan Schniepp, ÐÓ°ÉÂÛ̳ Inc.'s (ÐÓ°ÉÂÛ̳) Distinguished fellow go over how the people, processes, and documentation all come...
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Case Studies

Strategy for Pharmaceutical Submission

A major manufacturer of IV pharmaceuticals was facing leakage problems with the IV bag. ÐÓ°ÉÂÛ̳ suggested a CBE 30, which they submitted to the FDA, addressing product complaints and maintaining...
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Case Studies

21 CFR Part 11 Gap Analysis

ÐÓ°ÉÂÛ̳ was contracted to perform a gap assessment of eight quality software systems and 29 laboratory software systems. After reviewing remediation plans, the FDA chose not to make a regulatory...
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Podcasts

Protocol Design for Biologics

In this episode of ÐÓ°ÉÂÛ̳ Radio, host Brandon Miller, Steve Lynn, ÐÓ°ÉÂÛ̳ Inc.'s (ÐÓ°ÉÂÛ̳) Executive VP of Pharmaceuticals, and Walter Mason, ÐÓ°ÉÂÛ̳'s Sr. Director of Quality Control and...
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Podcasts

2021 Industry Outlook – Pharmaceuticals

In this episode of ÐÓ°ÉÂÛ̳ Radio, host Brandon Miller and Steve Lynn, who is ÐÓ°ÉÂÛ̳ (ÐÓ°ÉÂÛ̳) Executive VP of Pharmaceuticals, provide an outlook into the most important things...
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