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Q&A: The IND Journey Phase I – Navigating Success

Advarra

The sponsor is the pharmaceutical company conducting the trial. The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. A: Working in a pharmaceutical company is the best way to learn this. A: This does not usually happen.

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Reflections on life science’s regulatory environment  

Drug Discovery World

Remco Munnik (RM): Up to now, regulatory has always been the spider in the web within a pharmaceutical company – collecting all of the relevant information for submission of the registration: Clinical, CMC, administrative data, etc – then compiling a valid eCTD by the submission deadline.

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Scaling Phage Therapy

Codon

Regulators traditionally want to see a single, stable, well-characterized drug before giving the green light for it to be tested in a clinical trial, not dozens of different viruses; let alone ones that are best found in unappealing places like sewage , hospital waste, or bird poop.

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