Lörrach Germany
Normec Heppeler Institute
Expert laboratory for chemical and microbiological analysis in pharmaceuticals, cosmetics, and water quality
Our institute specialises in advanced chemical and microbiological analysis, focusing on pharmaceuticals, active ingredients, cosmetics, and various water types, including drinking water, bathing water, and wastewater. As a GMP-certified laboratory inspected and approved by the German Medicinal Products Agency and the FDA, we excel in method development, validation, and testing under GMP conditions.
Available for all your questions and requests
Do you have a question? Are you curious about the opportunities we see for you or can create together with you? Contact one of our companies.
Normec Heppeler Institute
Pharmaceutical quality control testing
We perform comprehensive quality control testing of raw materials and active pharmaceutical ingredients (APIs) to ensure they meet regulatory and pharmacopeial standards. From identity and purity to assay and impurity profiling, our analyses provide the critical data you need for safe and compliant pharmaceutical production.
Stability testing and sample storage
We provide reliable stability testing and sample storage for both APIs and finished pharmaceutical products under fully controlled conditions. From ICH-compliant climate chambers to custom study setups, our services ensure the integrity of your products over time. With thorough documentation, trend analysis, and secure sample management, we help you meet regulatory requirements and maintain product quality throughout its shelf life.
Pharmaceutical Impurity Profiling
Elemental impurities, residual solvents & nitrosamines – tested with precision GMP-compliant and aligned with ICH Q3D, USP <232>/<233>, EP 2.4.2 / 5.20 Including cleaning validation & verification for your development phases.
Analytical method development and validation
We develop and validate analytical methods in line with cGMP and ICH guidelines. We support pharmaceutical and medical device companies by ensuring methods are robust, reliable, and regulatory-ready — from initial setup to full validation and cleaning verification.
GMP-Compliant analytical services you can rely on
Our laboratories are equipped with state-of-the-art technology for complex analyses, such as heavy metal testing, corrosion studies, pesticide and pharmaceutical residue analysis in aqueous matrices, volatile halogenated hydrocarbons (VHC), organic solvents, and mineral oils. We also offer stability studies, viscosity, density, hardness, and refractive index measurements, as well as in vitro dissolution testing. All analyses are conducted under GMP conditions, and we develop and validate analytical methods in accordance with ICH guidelines.
With accreditations from leading authorities such as the German drug regulatory agency and the FDA, as well as our comprehensive quality assurance program, we guarantee the reliability and regulatory compliance of our results. External laboratory audits, official inspections, and interlaboratory comparisons continuously ensure the quality of our analyses. Our team of experts takes a solution-oriented approach to your specific needs and supports you in achieving your safety, quality, and regulatory goals.
Curious about what drives us? Watch our video and discover who we are and what we stand for.
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:
Our team
Expert, enterprising and ambitious
Felix Heppeler
Managing Director
Dr. Axel Heppeler
Managing Director
Vincent Bremmer
Managing Director
Job vacancies
Working at Normec Heppeler Institute
Discover our current job vacancies
Working at Normec Group
At Normec Group, we are driven by quality, innovation, and impact. Across various industries from healthcare to construction and beyond, we work together to ensure safety, compliance, and continuous improvement. With a strong team spirit and room for personal growth, we offer a workplace where your expertise truly matters. Curious about your opportunities with us? Visit our career page to view all current vacancies.
¿Quiere crear un entorno laboral y vital seguro y saludable?
Contacto