Impurity deficiencies in submissions are remarkably consistent. Subathra Ramamoorthy, Veranova, explains how to catch them before agency filing.
|Articles|May 25, 2006
Chemir Analytical Services Acquires Gateway Chemical
Author(s)Patricia Van Arnum
Chemir Analytical Services (Maryland Heights, MO) acquired Gateway Chemical Technology, Inc., (St. Louis, MO), a provider of custom synthesis and process development services.
Advertisement
Chemir Analytical Services (Maryland Heights, MO,
"The purchase of Gateway Chemical Technology is a key step in our nextlevel of growth" said Shri Thanedar, PhD, CEO of Chemir, in a companyrelease. "In fact, we plan to expand soon to a new building. This willbe a dedicated CGMP/FDA regulated laboratory, perfect for our growingstaff of pharmaceutical chemists."
Chemir will expand its Maryland Heights facility from 25,000 to 50,000ft2, with a staff projected at 100 by 2008.
Advertisement
Related to this article
Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.
Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 about formulation and characterization challenges for amorphous solid dispersions.
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
Jaenisch, Muraru, and Pandey discuss how regulators will audit pharma against its own AI policies and ways QA and regulatory teams can build defensible, inspection-ready AI practices.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Late-Phase Impurities Need Reference Standards: AAPS PharmSci 360 2026
2
Improving Oral Peptide Delivery Through Structural Modifications
3
Using OEE Monitoring to Justify Expenditure on Aging Production Lines
4
Drapeau’s AI Deep Dive: The Price of Acceptance in Regulated AI
5