Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Biopharmaceutical Manufacturing Process Validation (Nov 17th - Nov 18th, 2025)" training has been added to ResearchAndMarkets.com's offering. This ...
Completes a Substantial Requirement Toward the Planned Submission of D-PLEX 100 NDA and MAA Regulatory Filings PolyPid’s ongoing Phase 3 SHIELD II trial of D-PLEX 100 for the prevention of surgical ...
The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...
FDA’s 21 CFR Part 820 — Quality System Regulation (QSR) has not been updated since it was first released in 1996 . . . until now. Are you ready? Part of a panel at the conference discussing the ...
Poly(3-hydroxyalkanoates) (PHA) are biodegradable polyesters produced by various bacteria, including Cupriavidus necator. The composition of PHA depends on the type of microorganism, cultivation ...
The pultrusion line and the dedicated production hall fulfill stringent requirements in terms of cleanliness, manufacturing process validation and quality control. Both assets are qualified for ...
Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...
(MENAFN- GlobeNewsWire - Nasdaq) This training session presents opportunities in enhancing compliance and efficiency in drug manufacturing by deepening understanding of FDA and EU guidelines, ...
PETACH TIKVA, Israel, Sept. 19, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced ...
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