Chromicent GmbH
Profile
Chromicent GmbH, based in Berlin-Adlershof, develops and validates chromatographic analytical methods under Quality by Design (QbD) principles and analyses impurities for clients. The company also carries out GMP audits at contract laboratories.
Services
Evidenced: named on the company’s own website. Unclear: checked, nothing conclusive found.
| Service | Status | EvidenceQuote from the company’s website (German) |
|---|---|---|
| Analytical method development and validation Testing and analytics |
Evidenced |
„Analytische Methodenvalidierung in compliance mit regulatorischen Vorgaben (ICH Q2)“ Source · 10 Nov 2026 ↗ |
| GMP audits and supplier qualification Release and quality |
Evidenced |
„Durchführung von GMP-Audits gemäß Kundenanforderung, z.B. bei externen Auftragslaboren oder Lohnherstellern“ Source · 10 Nov 2026 ↗ |
| QM and GMP consulting Release and quality |
Evidenced |
„Selbstinspektionen in compliance mit EU-GMP Richtlinien zur Vorbereitung von Firmen- und Behördeninspektionen“ Source · 10 Nov 2026 ↗ |
Official credentials
Manufacturing authorisation
The competent authority of the federal state authorises the site to manufacture, test or import medicinal products (Section 13 of the German Medicinal Products Act, AMG). Without this authorisation it may not do so.
DE_BE_01_MIA_2026_0036
Adlershof
Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗GMP certificate
The authority has inspected the site and confirmed that it complies with Good Manufacturing Practice (GMP).
DE_BE_01_GMP_2026_0066
Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗Sites
Wagner-Regeny-Strasse 8
12489 Adlershof