Particle Analytical ApS

Overview

PARTICLE ANALYTICAL is a dynamic company devoted to supporting customers within the field of particle science.

# PARTICLE ANALYTICAL focuses first and foremost on the pharmaceutical industry # PARTICLE ANALYTICAL offers a broad range of particle analytical methods # PARTICLE ANALYTICAL supports the following areas; R&D, production and quality assurance

PARTICLE ANALYTICAL has a fully equipped state-of-the-art laboratory.

PARTICLE ANALYTICAL ApS is approved as a GMP laboratory by the Danish Medicines Agency and FDA registred. The approval applies for both human and veterinarian medicinal products.

Standards & Methodologies

Advising PARTICLE ANALYTICAL advises on the possible consequences of variations in particulate material for processing characteristics. Further, we can help with the evaluation of critical parameters for excipients and active substances.

Development and validation Particle measurement is not an exact technique and therefore does not express a "true" value. A range of analytical techniques are available, and they all have their strengths and weaknesses. In order to develop and validate analytical methods it is necessary to correlate several methods.

Routine analysis PARTICLE ANALYTICAL acts as a contractor for routine analysis which are time consuming and economically unprofitable for many companies. The analytical instruments are an expensive investment and demand extensive qualification and specialized personnel to carry out and approve analyses.

Backup Many companies are vulnerable to breakdowns of analytical instruments because it may often take them months to re-establish the capacity. PARTICLE ANALYTICAL acts as a backup in the case of breakdowns or at low analytical capacity.

Qualifications, Certifications, Accreditations & Licenses

US FDA registered GMP certificate from DKMA