CRO Regulatory Affairs: Bridging Strategy, Compliance, and Speed Bringing a new therapy to patients is as much a regulatory journey as it is a scientific one. Every submission, meeting, and document must align perfectly with evolving international standards — from FDA INDs and NDAs to EMA CTIS, IMPDs, and the EU CTR framework. At Cromos Pharma, we view regulatory affairs not as an Read more
Clinical Research Focus. 45th Edition Trump Administration Weighs “Severe Restrictions” on U.S. Drug Licensing from China According to a New York Times report, the Trump administration is considering a draft executive order that would impose stricter oversight on U.S. pharmaceutical deals with Chinese biotech firms, including national security reviews of licensing agreements and tougher scrutiny of Chinese clinical trial data Read more
ISO 9001:2015 and ICH GCP E6(R3): Two Standards, One Language of Quality in Clinical Research Why these standards matter In today’s clinical research landscape, quality is not optional — it is the foundation of trust between sponsors, CROs, regulators, and, ultimately, patients. Two major frameworks set the tone: ISO 9001:2015, the world’s most widely adopted quality management standard, and ICH GCP E6(R3), the latest revision of Good Clinical Practice, finalized Read more
Clinical Research Focus. 44th Edition NIH Scientists Advance Gene-Editing Approach for Late-Onset Tay-Sachs NIH researchers have successfully used gene-editing to boost enzyme activity and ease symptoms of late-onset Tay-Sachs in human cells and mice. This breakthrough could pave the way for future therapies targeting Tay-Sachs and other lysosomal storage disorders. Learn more Milestone Achieved: Cromos Pharma Earns ISO 9001:2015 Certification Read more

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