Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...
Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...
Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company that is ...
Esco Aster, a vertically integrated cell and derivatives CRDMO based at JTC LaunchPad Singapore, announced CMC manufacturing support for Shine-On Biomedical's HLA-G targeted exosome program. Shine-On ...
GlobalData on MSN
Takeda and Protagonist seek FDA approval for rusfertide to treat PV
Takeda and Protagonist Therapeutics have jointly submitted a NDA seeking approval from the US FDA for rusfertide to treat ...
The Union Health Ministry is in talks with states about extending the deadline for pharmaceutical companies to meet new ...
Pharmaceutical Technology on MSN
Cellenkos gains FDA orphan drug status for CK0804 to treat myelofibrosis
Cellenkos has received orphan drug designation from the US FDA for its investigational CK0804 Treg therapy to treat ...
Medium on MSN
5 FDA vitamin labels and what they mean
Reading vitamin labels can sometimes be a mystifying experience. To help clarify, here are the various FDA vitamin labels and what they all mean.
The Union Health Ministry is holding discussions with state governments and drug regulatory authorities to consider granting ...
The health ministry is unlikely to extend the Schedule M deadline for MSME pharma firms beyond December 31, 2025, as it ...
MedPharm’s topical drug product manufacturing facility in Durham has successfully completed an FDA inspection for commercial ...
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