CMC ANALYSIS & QUALITY CONTROL – GMP CERTIFIED AND FDA INSPECTED CRO

METHOD DEVELOPMENT, VALIDATION & TRANSFER

Elemental Impurity

QUALITY CONTROL OF SMALL MOLECULES

Batch release

QUALITY CONTROL OF BIOLOGICS & BIOSIMILARS

GLP testing

BIOSIMILAR COMPARABILITY STUDIES

GMP testing

Batch Testing & Batch Release

Biosimilar testing

STABILITY STUDIES

Microbiology

N-Nitrosamines & Elemental & Other Impurity Testing

Quality Control

EXTRACTABLES & Leachables

ORALLY INHALED & NASAL DRUG PRODUCT TEST

Cell Based & Potency Assays

Testimonials

“We are currently developing multiple new biosimilar projects and consider Kymos one of the best CROs in Europe for drug release and testing.”

Yong Suk Yang, Global QC Operation Team Manager, CELLTRION, INC

“We were positively impressed when Kymos reacted to our needs by investing in their stability capabilities, and now, two years down the line, with projects in full-swing, I can safely say that we made the right choice. In Kymos we have found a reliable, committed, trustworthy and professional partner.”

Dr. Dino Mangion, Head of Malta Operations, MEDICHEM/COMBINO PHARMA Ltd

“Back in 2017 there weren’t many analytical CROs able to carry out Franz cell assays and Kymos’ pioneering work was pivotal for the registration of our product.”

Dr. Marius Strunk, Senior Pharmaceutical Development Manager, HELM AG

“Kymos offered superior historical expertise by being exposed to so many different clients, pharmacological compounds, and therapeutic areas. They addressed and anticipated very diverse problems.”

Dr. Pablo Avilés, PHARMAMAR S.A.

“I have had a long and fruitful experience with Kymos and have a huge interest in their participation owing to their reliability.”

Jaime Algorta, Medical Affairs Director , EXELTIS HEALTHCARE S.L.U.

“Prolytic is our analytical partner throughout the entire drug development process. Such a long and complex process requires a laboratory you can trust. Professional yet flexible, Prolytic accompanies us through the preclinical and clinical phases.”

“Establishing robust miRNA methods for valuable results is tricky. The team at Prolytic have been a key collaboration partner. With their 30 years of experience in bioanalytics and broad know-how in different techniques, study types, and substance groups, we were able to quickly develop a reproducible and reliable analysis method for miRNAs.”

Dr. Meike Saul, Research Group Leader, Technische Universität Darmstadt

Get in touch


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