Particle Analytical is approved as a GMP laboratory by the Danish Medicines Agency (DMKA) and registered with the FDA. The approval by DMKA applies to both human and veterinary medicinal products. The GMP certificate can be found in the EudraGMDP database.
Danish Medicines Agency
Particle Analytical is approved as a GMP laboratory by the Danish Medicines Agency.
Particle Analytical also has permission to handle controlled substances.
Particle Analytical is registered with the FDA (U.S. Food and Drug Administration) and has been inspected several times. Please use the contact form to ask for a certificate.
Have you received an FDA warning letter with similar wording to this:
“…Your firm has not identified the component attributes (e.g., solubility, viscosity, and particle size) and the process parameters (e.g., speed, temperature, and pH) that are important to produce this product with a consistent quality.”
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