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
Three 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 topicPharmaceutical logistics as a GDP interface
How specialist logistics centres control outsourced activities, qualification and operational GDP processes.
For this industry
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.