Small Molecules

GLP-certified bioanalysis and GMP-certified quality control of small molecules.

Services

All Small Molecules Services

Small molecules

Bioanalysis of Small Molecules & Generics

Development and validation of analytical methods for analysis of biological samples delivered mainly from pre-clinical and clinical studies.

LC-MSMS Sciex API 5500 QTrap

Bioequivalence Studies

Bioanalysis for bioequivalence studies of generics in collaboration with the sponsor and/or the selected clinical phase centre.

Sample preparation MS

Quality Control of Small Molecules

Analytical tests for APIs, excipients, intermediate products, finished products, packaging materials and process environment samples.

Test tube in laboratory

Method Development, Validation and Transfer

Development and validation of analytical methods for excipients, APIs, intermediate products and finished products.

Percutaneous Absorption

Percutaneous Absorption

Percutaneous absorption assays for topical semisolid drug products: In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT)

Climatic chambers for stabilty studies

Stability Studies

Full ICH studies and on-going stability programmes at different storage conditions.

Analytisches CRO HPLCs

Batch Testing and Batch Release

Our laboratories are GMP certified and we have a partial manufacturer authorization for Quality Control purposes.

Pharmakokinetic Evaluation

Pharmacokinetic Evaluation & Statistics

Pharmacokinetic calculations and statistics of bioanalytical data from preclinical and clinical studies with Phoenix WinNonlin®.

Oligo testing

Bioanalysis of Nucleic Acids

Quantification of nucleic acids as therapeutics, biomarkers or similar with standardized and reproducible methods according to GLP.

nitrosamines GC-MS

Elemental, Nitrosamines & Other Impurity Testing

We offer GLP Cell-based neutralizing antibody assays for biologics and GMP Cell-based potency assays for vaccines and other biologics.

SphereFlash automatic colony counter

Microbiology

Laboratory including cleanroom with airlock technology and HEPA filters for testing of sterile and non-sterile APIs and drug products.

extractables and leachables

Extractables and Leachables

Semi-quantitative screening for both volatile, semi-volatile and non-volatile organic compounds.

Biomarker Analysis

Biomarker analysis services across various therapeutic areas aided by our state-of-the-art equipment and multiplexing techniques.

image of dissolution test equipment for transdermal testing

Transdermal Testing

GMP and GLP-certified studies for transdermal patches during the whole life cycle of these products: from formulation and development to routine analysis.

PHARMAPROGRESS_Laboratory_OINPD_NGI_5-scaled

Orally Inhaled and Nasal Drug Products (Oindps) Testing

GMP-certified OINDPs testing for a broad range of delivery services including inhalers, nebulizers and nasal.

Histopathology

Histopathology Services

GLP-certified histopathology evaluation and consultancy services through our strategic partner Patconsult in order to complement our preclinical bioanalytical offer.

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Ask our experts

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Yong Suk Yang

Global QC Operation Team Manager

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

Dr. Dino Mangion

Head of Malta Operations

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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. Marius Strunk

Senior Pharmaceutical Development Manager

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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. Pablo Avilés

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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.

Jaime Algorta

Medical Affairs Director

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

OMEICOS THERAPEUTICS

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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.

Dr. Meike Saul

Research Group Leader

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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

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