Testen en vrijgave voor pharma en life sciences
Pharmaceutical quality control testing
We offer a wide range of physical, chemical and microbiological analysis for finished pharmaceutical formulations, APIs and excipients. As a certified GMP laboratory inspected and accepted by the German State Agency (Regierungspräsidium Tübingen Leitstelle Arzneimittelüberwachung) and the FDA (Department of Health and Human Services), we develop analytical methods, validate them according to the valid ICH guidelines and master chemical and microbiological analysis for the testing of medicinal products and active pharmaceutical ingredients in accordance with the applicable GMP guidelines.
You benefit from our pharmaceutical quality control - just rely on us
We arrange tailored solutions for your projects and ensure regulatory compliance.
Our team is highly motivated and finalize fast turn around times to avoid delays for your product market entry.
Strengthen your organization's image as a professional, quality-driven, and certified supplier in the pharma and life sciences sector and increase the reliability and safety of your pharmaceutical products through independent laboratory testing with us.
For entire assistance we serve with an integrated pick-up service for your samples and in special occasions provide an express service for urgent samples.
Our analysis includes the following:
Cleaning validations, analysis of rinse and swab samples
Colouring
Density determinations
Dissolution tests with paddle, basket and cylinder methods and subsequent content determination by HPLC, GC, UV, etc.
GC (FID, WLD, NPD) and GC-MS Grade Determination and Purity Determination
Hardnes tests of tablets with thicknesses and lengths and mass determination
Heavy metal investigations as limit determination
Heavy metal testing using ICP-MS, ICP-OES and AAS
HPLC/UPLC (DAD, VWD, RID, FLD, ECD, CAD) and HPLC-MS-MS grade and purity determinations
Hygiene monitoring with testing of the air microbial count and contact examination of surfaces Ion chromatographic examinations
IR Spectroscopy
Melting point determinations
Microbiological tests to test for sufficient preservation of non-sterile pharmaceutical preparations
Microbiological tests to test the quality of non-sterile pharmaceutical preparations
Microscopic examinations
Refractive Index Analyses
Residual solvent analysis using GC
Stability studies including handling and storage of stability patterns in GMP-monitored climate rooms
Thin layer chromatography
Titrations
TOC analyses for ultrapure water
UPLC Grade Determination and Purity Determination
UV absorption determinations
Viscosity Determination
Water content determination with Karl Fischer titrations
Purified Water testing
Purified Water, also called „Aqua purificata”, is special water used in the pharmaceutical and life science industry to manufacture pharmaceutical preparations. We test according pharmacopeia standards and help in case of contamination e.g. identification of biofilm indicating germs.
Betrouwbare resultaten, op tijd en volledig conform de regelgeving
Planning & Flexibility
Wij werken nauw samen met uw planningsafdeling om testtijdlijnen af te stemmen op uw productieplanning. Spoedvrijgave van een batch? Ondersteuning buiten kantooruren nodig? Onze flexibele planning zorgt ervoor dat uw deadlines op betrouwbare en conforme wijze worden gehaald.
Kwaliteit & veiligheid eerst
Ons laboratorium werkt onder GMP- en DIN EN ISO 17025 certificering, en is FDA-geregistreerd. Al onze processen volgen strikte kwaliteits- en veiligheidsprotocollen en worden ondersteund door een robuust kwaliteitsmanagementsysteem (QMS). Onze getrainde analisten, gevalideerde methoden en moderne apparatuur zorgen keer op keer voor betrouwbare, conforme resultaten.
Accreditations & Recognitions
We go for quality. For guaranteed results.
We continuously demonstrate the quality of our laboratory and its comprehensive quality assurance program through official inspections (Regional Council of Tübingen, Germany; FDA, USA), external laboratory audits, interlaboratory comparisons, control samples, and practical application. Our analysis are legally defensible and internationally recognized. Analysis in the field of pharmaceutical analytics are carried out under GMP conditions. Many authorities make use of our services. Our laboratory is:
These services might also be of interest to you
Ontwikkeling en validatie van analysemethoden
We ontwikkelen en valideren analysemethoden volgens cGMP- en ICH-richtlijnen. We ondersteunen farmaceutische en medische bedrijven met robuuste, betrouwbare en volledig conforme methoden — van de eerste opzet tot volledige validatie en reinigingsvalidaties.
Stabiliteitstesten en monsteropslag
Farmaceutische Onzuiverhedenprofilering
Leading companies in this service
Normec Heppeler Institute
Lörrach Duitsland