Mikle-Pharm GmbH
Profile
Mikle-Pharm GmbH, based in Landau in der Pfalz, advises pharmaceutical companies on regulatory affairs, marketing authorisation dossiers and project evaluation across the entire medicinal product lifecycle.
Services
Evidenced: named on the company’s own website. Unclear: checked, nothing conclusive found.
| Service | Status | EvidenceQuote from the company’s website (German) |
|---|---|---|
| QM and GMP consulting Release and quality |
Unclear |
„strategic advice in scientific and regulatory fields consultation on regular basis interim management“ Source · 10 Nov 2026 ↗ |
| Regulatory affairs Regulatory and safety |
Evidenced |
„compilation of application dossiers, submission, procedure management Agency communication, follow-up Scientific Advice SA, Clinical Trial Application CTA, Marketing Authorisation Application MAA“ Source · 10 Nov 2026 ↗ |
| Clinical trial application (CTA) Regulatory and safety |
Evidenced |
„dossier compilation: Briefing Document (for Scientific Advice), IMPD (for Clinical Trial Application), CTD/ e-CTD (for Marketing Authorisation Application)“ 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_RP_01_MIA_2023_0046
Landau In Der Pfalz
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_RP_01_GMP_2026_0038
Landau In Der Pfalz
Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗Sites
Sandgasse 17
76829 Landau In Der Pfalz