GMP-certified analytical laboratory: scope, compliance requirements, and what it guarantees for drug development partners
Every analytical result that ends up in a regulatory dossier makes an implicit promise. It says the result...
RNA therapeutics bioanalysis: quantification methods for siRNA and mRNA in preclinical PK studies and regulatory submissions
RNA therapeutics have moved from proof of concept to an established drug class in under a decade, with...
AMSbiopharma becomes the first analytical services laboratory in Galicia with GMP Certification for medicinal product quality control activities
The Spanish Agency for Medicines and Medical Devices certifies compliance with Good Manufacturing Practices at the Lugo-based laboratory...
Antisense oligonucleotide analysis by mass spectrometry: sequence confirmation, impurity profiling and CRO support for regulatory submission
Every antisense oligonucleotide (ASO) drug candidate carries a structural burden that small molecules never face: a polyanionic backbone,...
AMSbiopharma will be exhibiting for the first time with its own stand at Farmaforum 2026
Farmaforum, the leading national event for the biotechnology and pharmaceutical sector, will take place on 22 and 23...
Bioequivalence studies in drug development: study design, bioanalytical methods and regulatory compliance
Two formulations of the same active ingredient rarely behave identically in the body, and drug development depends on...
Mass spectrometry services for small molecule drug characterization: structural analysis, metabolite identification, and CRO support
Every small-molecule drug candidate must clear two analytical hurdles before it reaches a regulatory filing: confirmed chemical identity...
Hit-to-lead in drug discovery: analytical strategies for hit validation and lead optimization
Every small-molecule program begins with a deceptively simple question: Does this compound actually bind the target, and can...