Regulatory pressure
GDP guidelines, §52a AMG and authority inspections demand seamless structures and records.
Industry · Pharmaceutical Wholesale
Consulting for pharmaceutical wholesale.
Work in a GDP-compliant, audit-proof and economical way – we support you with quality, compliance and operational processes along the entire supply chain.
Challenges
Between authority requirements and day-to-day business.
Efficiency & supply chain
Warehouse and distribution processes must stay economical – with full quality assurance across all stages.
Responsibility
The Responsible Person needs clear responsibilities, lived processes and trained teams.
Services
Our consulting focus in wholesale.
- Wholesale authorisation under §52a AMG – application, extension and amendment.
- GDP-compliant quality systems – build and further development.
- Authority inspections & audits – preparation, support, follow-up.
- Responsible Person – training, coaching or taking on the role.
- Warehouse & distribution processes – optimisation and qualification of facilities.
- Training – for employees and Responsible Persons.
Knowledge
Two topics in detail.
Wholesale authorisation under §52a AMG
From application through QM documentation to the authority inspection – the path to authorisation, clearly structured.
To the topicWorking to GDP
What Good Distribution Practice means in everyday work – and how to meet the requirements without unnecessary bureaucracy.
To the topic
Consultation
Let's talk about your wholesale operation.
Whether authorisation procedure, GDP system or an upcoming inspection – we tell you honestly what is needed and what is not.