SERVANTIS complements operational logistics services with structured additional services, especially for regulated product groups:
Repackaging of secondary packaging
Assembly and bundling
Aggregation of serial numbers for pharmaceutical clients
Labelling
Advice on entering the national healthcare market
Handling of regulatory tasks
Customer qualification (new and re-qualification)
Contract controlling with KPI reporting
Our data management automatically provides relevant key figures and revenue reports.
Regulatory Affairs
The import, wholesale distribution and placing on the market of medicines in Germany are subject to the provisions of the German Medicinal Products Act (AMG), EU Directive 2001/83/EC and the relevant GxP regulations. All activities require an official authorisation, a suitable operational infrastructure and an effective quality management system.
SERVANTIS provides the complete operational infrastructure required for obtaining and maintaining a wholesale licence under Section 52a AMG or under Articles 76 et seq. of Directive 2001/83/EC.
This includes in particular:
Provision of suitable premises capable of official approval
qualified and validated warehouse and IT systems
Implementation and maintenance of a GxP-compliant quality management system
documented processes in accordance with GDP guidelines
Responsible person & partner network
The role of the responsible person under Section 52a AMG can be assumed by qualified staff from SERVANTIS quality management. This ensures that regulatory requirements are continuously monitored, evaluated and met.
In addition, through our specialised partner network, we enable the appointment of further legally required functions:
Qualified Person under Section 14 AMG
Head of Manufacturing under Section 12 AMWHV
Head of Quality Control under Section 12 AMWHV
Responsible Person under Section 52a AMG, if not filled internally
Our regulatory services are modular and can be adapted to the respective company phase – from market entry through building a wholesale structure to scaling existing activities.
Service modules
GxP quality management
Development, implementation and ongoing maintenance of a company-specific quality management system including SOP structure, risk assessment and CAPA management.
Audits
Preparation, support and execution of internal and external audits in accordance with GDP and GMP requirements, including regulatory inspections.
GxP service and consulting
Expert support with regulatory questions, process adjustments and structural changes.
Import and export
Support with the importation of medicines into the European Economic Area, including regulatory requirements under Section 72 AMG.
GxP services
Setup and maintenance of GxP quality management systems
Audit preparation and support
GxP consulting
Support with import and export processes under Section 72 AMG
Office & Facility Service
At its Hamburg site, SERVANTIS offers modern office and working space of 1,500 square metres for pharmaceutical and HealthCare companies:
dedicated office rooms
conference rooms
infrastructure and services
