Lot Release Testing

Quality Control analyses are routinely performed at Nelson Labs Europe according to GMP quality standards for Drug substances, Drug products, Intermediates, Starting materials and Excipients, intended for lot release testing.

Our highly-skilled and proactive analytical scientists, with state-of-the-art instrumentation enable us to deliver comprehensive analytical solutions for both API and drug product. For raw material and finished products quality control, we offer quality control and issuing of analytical certificates for raw materials, intermediates, active ingredients and finished products to be marketed in the European Union.  


Method transfer

Analytical methods can be transferred to or from the customer. Following ICH guidelines, GMP method transfer follows a formal process with transfer protocols and reports. Alternatively, the methods may have been developed and validated at Nelson Labs Europe previously, or they are simply compendial routine methods that are already in place at Nelson Labs Europe or requiring verification only.

 

Analytical Packages or Single Methods

Based on full cGMP compliance we can take over the entire Quality Control testing program of a product. In many cases, this option provides a cost-effective and trouble-free solution for our customer. You simply send us a sample of your product, and we deliver the results in a Certificate of Analysis signed by a Qualified Person or an analytical report that can be used to immediately release the product. Nelson Labs Europe can perform selected methods of your monograph, if this option is more suitable to fulfill your needs. 

Contact:


Nelson Labs Europe
Romeinsestraat 12
B-3001 Leuven
Belgium
+32.16.400484
InfoEurope@nelsonlabs.com

Nelson Labs Europe | Lot Release Testing