Consulting & Regulatory Services

Expert pharmaceutical consulting in GMP compliance, regulatory support for manufacturing and wholesale distribution authorisations, as well as quality management systems and audits. DAN-Pharma is your trusted partner.

Service Portfolio

Pharmaceutical Expertise You Can Rely On

We provide pharmaceutical expertise across a broad range of disciplines. Have questions? Do not hesitate to get in touch. Even if a specific service is not listed, we will work with you to find the right solution.

Our Services

01
Support with applications for wholesale distribution authorisations pursuant to Section 52a of the German Medicinal Products Act (AMG)
02
Support with applications for manufacturing authorisations pursuant to Section 13 of the German Medicinal Products Act (AMG)
03
Implementation and monitoring of quality management systems (QMS) in compliance with GMP and GDP requirements
04
GMP consulting and auditing services

Your Regulatory Partner

Navigating pharmaceutical regulations can be complex. Our team of experienced pharmacists provides hands-on support for obtaining manufacturing and wholesale distribution authorisations, quality management, and compliance—allowing you to focus on your core business.

Quality Management Systems

We support you in the implementation and maintenance of robust quality management systems (QMS) in compliance with GMP and GDP requirements. From initial setup to ongoing monitoring, our team ensures that your operations meet the highest standards.

GMP Auditing

Our GMP auditing services provide comprehensive assessments and actionable recommendations to ensure your facilities remain compliant and audit-ready.

Reporting Adverse Reactions
Phone: +49 5861 983258 / Email: info@danpharma.de