AMSbiopharma

Advanced Analytical CRO: where your needs find solutions

We provide analytical services to support the pharmaceutical, biopharmaceutical, and chemical industries at every stage of drug development

Services

R&D and Preclinical

Advanced analytical support for drug research and preclinical development

Quality control

Comprehensive services to ensure the highest standards
of quality and safety

Do you want to speak with a quality control scientist?

About us

Your trusted analytical CRO, partnering with industry leaders to offer tailored solutions and close communication. AMSbiopharma is the alternative for pre-clinical and quality control services, offering accuracy and reliability at every step

News

Peptide mapping for biopharmaceutical characterization: LC-MS/MS workflows, PTM analysis, and ICH Q6B compliance

Structural complexity is one of the defining challenges of biopharmaceutical development. Unlike small-molecule drugs, large protein therapeutics (monoclonal...

Host cell protein detection in biologics: LC-MS/MS strategies for HCP clearance and regulatory compliance

Every biopharmaceutical produced in a living cell system carries an unavoidable burden: the proteins expressed by the host...

ICH Q11 development and manufacture of drug substances: analytical and process strategies for robust CMC principles implementation

Drug substance development sits at the foundation of every pharmaceutical program, yet it is often where the most...

ICH Q8 guideline for pharmaceutical development: analytical strategies for quality by design in complex drug modalities

Regulatory expectations for pharmaceutical development have evolved considerably over the past two decades, from a compliance-driven and empirical...

Peptide purification in drug development: methods, techniques, and analytical strategies

The growing pipeline of peptide-based therapeutics has placed peptide purification at the center of pharmaceutical manufacturing strategy. From...

Metabolomics and lipidomics in drug discovery and development: analytical approaches for biomarker discovery and preclinical research

The search for safer, more effective medicines increasingly depends on understanding how biological systems respond to disease, genetic...

Drug development timeline: how early characterization prevents regulatory delays

The modern drug development timeline is highly shaped by manufacturing readiness, analytical understanding, and regulatory alignment. While innovation...

Chemistry, Manufacturing, and Controls (CMC) in the drug development process: analytical strategies to support Investigational New Drug (IND) readiness and regulatory progression

The transition from discovery to clinical evaluation represents one of the most critical inflection points in the drug...