batchrelease.eu

„WESSLING guarantees entry to the EU market for your finished product”

Batch Release

WESSLING Hungary Kft. is an independent European Batch Release Site with GMP certificate for EU compliant release of batches. With the cooperation of a group of different manufacturing and logistics players, providing the possibility for tailor made, cost-effective and comprehensive solutions.

Setup of work, data and product flow from a non-EU manufacturer to the EU-wholesaler

Elaboration of contract details according to the requirements of the European Health Authorities

Providing API declaration for the submission of New Product Application to the European Regulatory Authorities

Consulting about European Quality Assurance Compliance issues utilizing the high level of expertise of our pharmacists

Evaluation of batch control data given by our laboratories

Batch certification for the EU markets

Investigation of the root cause of OOS (out of specification) analytical results

Preparation of Batch specific variation application in case of justifiable OOS

Qualified Person’s discretion in case of justifiable OOS


Managing DayOne Launches according to the planned launch sequence based on patent expiry, using our contracted logistics team for organizing our in-house solutions for

Time critical transportation of the released batches from Hungary to the EU-customers, with

Thermo-controlled vehicles (heated/cooled), supported by an online tracking system

 

 

 




WESSLING HUNGARY Kft.

1045 Budapest, Anonymus u. 6.
Tel.: 06 1 872 3600
Fax: 06 1 435 0100
www.wessling.hu

batchrelease.eu