Pharmaceuticals & Cosmetics
Pharmaceutical and cosmetic testing
(Microbiology, stability & product quality)
Pharmaceutical and cosmetic products as well as microbiological testing and stability analyses.
Makrolife offers specialized analyses and testing procedures for pharmaceutical and cosmetic products, as well as for shelf-life and stability assessments. Our services include microbiological testing, preservative efficacy tests (PET), analysis of ingredients and impurities, and shelf-life studies to determine product stability and minimum shelf life. In this way, we support companies in quality assurance, product safety, and regulatory compliance.
Our study & testing areas
Comprehensive studies, tests & analyses according to
international accredited laboratory standards and ISO standards
Shelf life study for cosmetic products
Accelerated stability and compatibility testing with durability estimation.
from EUR 449.00
Challenge Test / Preservative Challenge Test
Testing to determine whether the preservation system of a cosmetic product adequately controls microbial contamination during use and storage.
from EUR 339.00
Microbiological quality testing for cosmetic products
Testing of the microbiological quality of the finished cosmetic product in accordance with ISO 17516 to ensure that germ count and relevant microorganisms are within permissible limits.
from EUR 249.00
Dermatologischer Patch Test / Skin Compatibility Test
It demonstrates skin compatibility, irritation potential and supports claims such as "dermatologically tested" or "suitable for sensitive skin"; the EU safety assessment focuses on local toxicity, skin/eye irritation and sensitization.
from EUR 2200.00
Claim substantiation / proof of effectiveness
Claims such as “moisturizing”, “soothing”, “anti-aging”, “anti-inflammatory” or “wound-healing” must be supported by appropriate and verifiable evidence from cell studies.
from 1200.00 EUR
GMP for cosmetics / Good Manufacturing Practice
Process auditing: GMP describes the quality requirements for the manufacture, control, storage and shipping of cosmetic products to ensure that every product is consistently safe and
is produced in a controlled manner.
Cosmetics GMP ISO 22716 (Remote/On-site auditing)
from 4900.00 EUR
In-vitro skin sensitization test according to OECD 442E / h-CLAT
Testing the skin sensitization potential of a product or ingredient by activating human immune cells.
The test helps classify whether a substance is potentially skin-sensitizing and can be performed under GLP conditions.
from 12000.00 EUR
Skin sensitization test according to ISO 10993-10
Testing to determine whether a material or product can trigger allergic or immunological reactions upon skin contact.
The test is primarily used for medical devices; for cosmetics, a patch test or OECD 442E would usually be more relevant.
from EUR 6800.00
Elemental impurities in pharmaceuticals (ICH-Q3D and Ph. Eur. 5.20)
Determination of elemental impurities in pharmaceutical raw materials and finished products.
from EUR 1,250.00
Microbiological analysis of pharmaceuticals and cosmetics (Ph. Eur. 2.6.12, Ph. Eur. 2.6.13)
Microbiological test kit for pharmaceutical and cosmetic products according to the European Pharmacopoeia.
from 350.00 EUR
Testing of preservation efficiency (PET) in medicinal products (Ph. Eur. 5.1.3)
Testing for the antimicrobial efficacy of preservative systems in pharmaceutical products.
from EUR 1,200.00
Fragrance allergens in cosmetic products (Regulation (EC) No 1223/2009)
GC-MS/MS screening for declarable fragrance allergens in cosmetic products.
from EUR 960.00
Shelf life study for food, feed or dietary supplements
Determining the shelf life until the best before or use-by date.
from 400.00 - 6000.00 EUR
Microbiological quality testing of food, feed and supplements
Microbiological tests for the quality assessment of food and food supplements.
from 320.00 EUR
Microbiology – Enterobacteriaceae (EN ISO 21528-2)
Detection and enumeration of Enterobacteriaceae in foods and food supplements.
from 250.00 EUR
Preservatives – Benzoic acid and sorbic acid (HPLC-UV)
Determination of the preservatives benzoic acid and sorbic acid in food.
from 260.00 EUR
Nitrosamines in pharmaceuticals and cosmetics
Determining the shelf life until the best before or use-by date.
from EUR 680.00
Testing of preservation efficiency (PET) in medicinal products (Ph. Eur. 5.1.3)
Microbiological tests for the quality assessment of food and food supplements.
from EUR 980.00
Pharmaceutical residues in untreated wastewater (Directive (EU) 2024/3019)
Detection and enumeration of Enterobacteriaceae in foods and food supplements.
from EUR 780.00
Elemental impurities in pharmaceuticals (ICH-Q3D and Ph. Eur. 5.20)
Determination of the preservatives benzoic acid and sorbic acid in food.
from EUR 780.00
