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.
Certifications
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:
Accreditation according to DIN EN ISO/IEC 17025:2018-03
Accredited according to DIN EN ISO/IEC 17025 (2018) for the scope listed in certificate D-PL-14527-01-00.
GMP certified laboratory according to § 14 (4) of the German Medicines Act
FDA
Approved testing laboratory according to §19 paragraph 2 sentence 4 of the Drinking Water Ordinance
Authorization to handle pathogens in accordance with Section 19 of the Infection Protection Act
Our team
Expert, enterprising and ambitious
Felix Heppeler
Managing Director
Dr. Axel Heppeler
Managing Director
Olivier Defline
Managing Director Healthcare and Pharma
Olivier is Managing Director of Healthcare and Pharma at Normec. He has held senior management roles in the Testing, Inspection, Certification and Compliance (TICC) industry across Europe and Asia, including leading Asia-Pacific at Eurofins and later serving as Group COO for support functions. Before Eurofins, Olivier worked at PPG Industries as General Manager for Retail Architectural Coatings in South-West Europe. He began his career at Oliver Wyman, focusing on strategy and performance improvement. Olivier holds a Master of Science in Mechanical Engineering from CentraleSupélec.
A career at Normec Heppeler Institute
Normec Heppeler Institute, located in the tri-border region, with a family-run business and global network.
International companies in the pharmaceutical and cosmetics industries have entrusted us with their products for over 70 years. We test and inspect medications, cosmetics, and other pharmaceutical products for safety.
Curious about the opportunities available to you? On the vacancy page for each area of expertise, you will find all current vacancies within your field at Normec.
Do you want to create a safe and healthy working and living environment?
Our latest news articles
24 Aug 2025
From Lörrach to Normec – The Journey of the Normec Heppeler Institute
13 Aug 2025