Many drug–device combination products can be developed to achieve the therapeutic goal and still face significant challenges in the manufacturing phase. Laboratory performance might be different from ...

PFAS exposure for device manufacturers no longer hinges on a single rule or a single material. FDA has drawn a firmer line around fluoropolymers, yet state reporting requirements, a still-evolving EU ...

For the better part of a decade, the default advice handed to medtech founders planning a first-in-human (FIH) study fit in three words: go to Australia. The pitch was seductive and, for a while, ...

Regulatory exemptions for essential PFAS uses in pharmaceuticals can create a false sense of security. Reporting duties, wastewater and solid waste obligations, CERCLA liability, and a major ...

A clean GLP audit or a smooth pre-IND interaction feels like proof of control, yet companies that pass inspections still hit submission delays and longer diligence cycles as programs advance. The ...

Familiarity can make manual quality systems look sturdier than they are. Spreadsheets, shared drives, and siloed eQMS platforms may feel dependable until an inspector starts tracing a document history ...

Drug delivery supply chains can become complicated quickly. Every handoff adds time, cost, communication risk, quality risk, and accountability gaps. Medbio’s model is built to reduce that complexity.

AI-assisted drafting of CAPAs, deviation write-ups, and regulatory correspondence is probably already happening on your quality team, with no policy and no record. This paper argues the exposure is ...

A clean audit does not necessarily mean a medical device company is prepared for its next submission, product launch, or acquisition. Teams may pass audits consistently while still reconstructing ...

A single swap, say a fluoropolymer gasket or filter, can force requalification, validation and refiling. Fluorine sits in a meaningful share of APIs, and fluoropolymers run through tubing, stoppers, ...