Pharmaceutical service provider for import, GDP logistics, packaging (§ 13 AMG) and distribution of medicinal products.
Paesel + Lorei GmbH & Co. KG
RheinbergNew on Amplifa
About Paesel + Lorei
Paesel + Lorei GmbH & Co. KG is a family-run service provider that has been serving the German and international pharmaceutical market since 1965. Originally founded as an importer of foreign pharmaceutical specialties pursuant to § 73 (3) AMG (German Medicines Act), the service portfolio today comprises pharmaceutical wholesaling and distribution, warehousing and distribution (including narcotics special logistics and cold chain logistics), import including customs clearance, as well as the manufacturing and packaging of secondary packaging pursuant to § 13 (1) AMG. The packaging services include packing, repacking, labelling, exchange of package leaflets and folding boxes as well as relabelling of blister strips and bottles; batch sizes range from a few hundred to 40,000 packages. Further fields include the sourcing of investigational medicinal products for clinical trials, sample shipping, promotional material logistics, licensing, and financial services such as invoicing and debt collection. Since 2016 the headquarters have been located in Rheinberg at Nordring 11, conveniently situated near the Kamp-Lintfort interchange (A40, A42, A57); all processes are GMP- and GDP-compliant.
- Site
- Rheinberg
- Processes
- Manufacturing / packaging of medicinal products (§13 (1) AMG): packing, repacking, labelling,, Warehousing and distribution (import, incoming goods inspection, temperature-controlled storage,, Pharmaceutical logistics including special logistics for narcotics and cold chain logistics, Wholesale and distribution of medicinal products (GDP-compliant), Import of foreign pharmaceutical specialties pursuant to § 73.3 AMG incl. customs clearance, Sourcing and supply of medicinal products for clinical trials (investigational medicinal products),, Distribution of pharmaceutical OTC products via field sales, licensing and out-licensing,, Pharmaceutical wholesale and distribution
- Materials
- Manufacturing/packaging (§ 13 (1) AMG), Warehousing and Distribution, Import pursuant to § 73.3 AMG, Narcotics Special Logistics, Cold Chain Logistics, Sourcing for Clinical Trials, Financial Services
- Certificates
- GMP certificate, GDP compliance, GMP certificate (available in the Eudra-GMDP database)
- Founded
- 1965
- Industries
- Pharmaceutical industry, Healthcare, Healthcare / pharmacies (public pharmacies, hospital and, Cosmetics / dietary supplements
- 01
Import or procurement of goods (incl. customs clearance)
- 02
Incoming goods inspection
- 03
Temperature-controlled storage (+2 to +8 °C / +15 to +25 °C)
- 04
Order intake and picking
- 05
Manufacturing/packaging pursuant to § 13 (1) AMG (packing, repacking,
- 06
Dispatch
- 07
Invoicing, debt collection and reporting
- 08
Complaint, recall and destruction management
Services and Processes
Manufacturing/packaging (§ 13 (1) AMG)
Packing, repacking, labelling, exchange of package leaflets and folding boxes as well as relabelling of blister strips and bottles in temperature- and access-controlled areas.
Warehousing and Distribution
Batch-controlled storage according to FEFO, picking and dispatch of medicinal products, narcotics and OTCs including electronic narcotics delivery records.
Import pursuant to § 73.3 AMG
Import of foreign pharmaceutical specialties including customs clearance for public pharmacies as well as hospital and university pharmacies.
Narcotics Special Logistics
Warehousing and distribution of narcotics including documentation and semi-annual reporting.
Cold Chain Logistics
Temperature-controlled storage and distribution of refrigerated products at +2 to +8 °C nationally and internationally.
Sourcing for Clinical Trials
GDP-compliant worldwide sourcing, import handling, warehousing and dispatch of investigational medicinal products to participating trial centres.
Financial Services
Invoicing, control and posting of incoming payments, dunning and reporting.
Site
Rheinberg
DEHeadquarters: warehousing, logistics, manufacturing/packaging, distribution
- Lot size
- a few hundred to 40,000 packages per batch
- Materials
- Medicinal products, narcotics, OTCs
- Temperature-controlled warehouses (+2 to +8 °C and +15 to +25 °C)
- Customs warehouse/free zone storage
- Narcotics warehouse
- Air-conditioned manufacturing areas
Services
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacturing / packaging of medicinal products (§13 (1) AMG): packing, repacking, labelling,Assembly | – | – | – | a few hundred packages – 40,000 units per batch | Medicinal products, Narcotics, OTC products |
| Warehousing and distribution (import, incoming goods inspection, temperature-controlled storage,Assembly | – | – | – | – | Medicinal products, Narcotics, OTC products |
| Pharmaceutical logistics including special logistics for narcotics and cold chain logisticsAssembly | – | – | – | – | Medicinal products, Narcotics |
| Wholesale and distribution of medicinal products (GDP-compliant)Assembly | – | – | – | – | Medicinal products |
| Import of foreign pharmaceutical specialties pursuant to § 73.3 AMG incl. customs clearanceAssembly | – | – | – | – | Medicinal products |
| Sourcing and supply of medicinal products for clinical trials (investigational medicinal products),Assembly | – | – | – | – | Medicinal products, Investigational medicinal products |
| Distribution of pharmaceutical OTC products via field sales, licensing and out-licensing,Assembly | – | – | – | – | Medicinal products, cosmetic products, dietary supplements |
Additional services
Reference customers
Quality and Compliance
The quality management system is based on the AMG, AMWHV and AM-HandelsV as well as the EU GMP and EU GDP guidelines; all processes are SOP-controlled, systems are qualified and the ERP system is validated. All functions relevant under medicines law (including Qualified Person, quality assurance, narcotics responsible person) are staffed, and release is performed by the Qualified Person.
| Evidence | Rheinberg |
|---|---|
| GMP certificate (available in the Eudra-GMDP database) | |
| GDP compliance |
History
- 1965
Founded in Frankfurt am Main for pharmaceutical import
- 1984
Distribution rights for a medicinal product in Europe and Asia
- 1993
Pre-launch of various medicinal products pursuant to § 73.3 AMG
- 1994
Warehousing and distribution of narcotics
- 1995
First import of medicinal products for clinical trials
- 1996
Leasing of warehouse space in the Duisburg inland port for customs warehousing
- 1998
Opening of the Duisburg branch for warehousing and logistics
- 1999
Logistics services and debt collection for medicinal products and OTCs
- 2005
Complete relocation to Duisburg in the inland port
- 2006
Marketing authorisation holder for medicinal products, distribution as pharmaceutical entrepreneur
- 2011
Sole distribution rights for various OTCs
- 2012
Sample shipping and promotional material logistics
- 2016
Relocation to Rheinberg; marketing authorisation holder of Impavido
- 2017
Expansion of warehouse capacity, takeover of an additional warehouse
- 2018
GMP certificate available in the Eudra-GMDP database