Nieuwegein Netherlands
Normec Synergy Health
We deliver specialised testing and quality control for pharma and life sciences.
At Normec Synergy Health, we are committed to providing accurate and reliable testing solutions for the pharmaceutical and healthcare industries. Our experienced team of scientists and analysts specialise in microbiological and chemical analyses, stability studies, analytical method validation and environmental monitoring. In doing so, we maintain the highest quality and compliance standards and work according to cGMP regulations and accredited methodologies. Our mission is to support clients in ensuring product safety and compliance, while continuing to innovate in pharmaceutical research.
Available for all your questions
Do you have a question? Are you curious about the opportunities we see for you or can create together with you? Please contact us.
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.
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.
Elemental impurities testing
We provide cGMP-compliant elemental impurities testing for pharmaceuticals using advanced techniques like ICP-MS and AAS. Aligned with USP, EP, and ICH Q3D guidelines, our analyses ensure regulatory compliance and product safety through precise detection and reliable documentation.
Method Transfer
We guide and support to transfer an analytical method from one to another laboratory. Together with you, we will find the right model for transfering your method within regulatory boundaries.
The safety of your products is our mission
With over half a century of experience in pharmaceutical product testing, Normec Synergy Health offers Internationally recognized centres of excellence in pharmaceutical and medical device testing in the areas of chemistry and microbiology. We consider honesty and integrity essential in building relationships that benefit our customers. At Normec Synergy Health, we offer a full range of services and act as a flexible partner in product testing and cGMP Quality Control — helping your business thrive.
OUR COMPANY IN NUMBERS
Methods of analysis
500
Years of experience
60
Projects per year
4000
Accreditations & Recognitions
We strive for quality. For guaranteed results.
Normec Synergy Health is certified for GMP, ISO 13485, and is FDA registered and WHO prequalified. We are also approved by the Lebanese Ministry of Health, the Belgian FAMHP (FAGG), and we are licensed for handling restricted substances. With over 60 years of experience, we have built a strong Quality Management System (QMS) that meets the highest pharmaceutical standards. Our QA experts ensure full regulatory compliance in line with EudraLex Volume 4 GMP guidelines. All employees are thoroughly trained, and we use validated methods and qualified equipment to deliver consistently high-quality results. For specific tests not performed in-house, we collaborate with other GMP-certified labs — only with written client approval.
Accreditation
GMP certificate (Chemical and Microbiological)
Normec Synergy Health is GMP-certified by the Dutch Health and Youth Care Inspectorate (IGJ) for quality control testing of human and veterinary medicinal products. View the full and current certificate.
Accreditation
GMP certificate (Veterinary)
Normec Synergy Health is GMP-certified for quality control testing of veterinary medicinal products. View the full and current scope of this certification.
Accreditation
FDA-registered
Normec Synergy Health is accredited by the FDA for drug product registration. View the full and current certificate of this accreditation.
Accreditation
WHO prequalified control laboratory
Normec Synergy Health is prequalified by the World Health Organization (WHO) as a quality control laboratory. View the full and current scope of this prequalification.
Accreditation
Manufacturers license
Normec Synergy Health is licensed by the Dutch Health and Youth Care Inspectorate (IGJ) as a pharmaceutical manufacturer for quality control testing. View the full and current scope of this license.
Accreditation
ISO 13485 license
Normec Synergy Health is ISO 13485 certified for quality management systems related to medical devices. View the full and current scope of this accreditation.
FAQ
The most frequently asked questions
We offer testing services for the pharmaceutical, healthcare and medical device industries.
Our Quality Management System (QMS) is built on GMP and ISO 13485 standards. All our staff are highly trained, and our procedures are regularly audited to ensure accuracy, compliance, and consistency.
Yes, we provide microbiological services for both sterile and non-sterile products, including sterility testing, bioburden determination, and endotoxin analysis.
Turnaround times depend on the type of analysis required, but we always aim to deliver fast, reliable results and can accommodate urgent requests where possible.
Yes, for tests we cannot perform in-house, we work with trusted GMP-certified partner labs. We do this only with written approval from the client.
You can contact us via the form on our website or email us directly. We’ll guide you through the process and provide all necessary instructions for safe sample submission.
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