Good Manufacturing Practices (GMP) Batch Release Testing

Good Manufacturing Practice (GMP) batch release testing or lot release testing across a range of products including pharmaceuticals, inhalation products and biologics therapeutics

Good Manufacturing Practice (GMP) batch release testing is a necessary requirement to ensure high quality pharmaceuticals and biopharmaceuticals prior to release for sale, supply or export.
 
Whilst you focus on your core business activities, you will need to select a partner with a strong history of delivering regulatory compliant batch release testing to a consistently high standard.
 
Our batch release testing teams utilise a wide range of analytical technologies to provide responsive release testing to ensure that healthcare products meet the product specification within the Marketing Authorisation (MA) or Clinical Trial Dossier (CTD). 
 
Batch release testing expertise includes chemical, physical and biological testing (including pharmacopeia analysis methods (BP, EP, JP and USP)). Our teams, based in our GMP compliant analytical laboratories, routinely work with clients around the globe to ensure that appropriate method transfer is performed. 
 
We provide batch and lot release testing for active pharmaceutical ingredients (APIs), investigational medicinal products (IMPs) and finished products with Marketing Authorisation across a wide range of pharmaceutical products including inhalation products and biologic therapeutics.
 
With a long history of batch release and lot release testing, our highly skilled scientists routinely conduct testing programs for clients around the world from our global network of GMP compliant analytical laboratories in North America and Europe. We tailor our release testing programs to your requirements and can provide services for the most basic of tests through to more specialised techniques.
 
Our clinical trial supply manufacturing services provide Qualified Person (QP) release in addition to GMP batch release testing according to the EU Directive and Medicines for Human Use (Clinical Trial) Regulations.
 
Need help or have a question? +1 800 967 5352
 

Need help or have a question?

+1 800 967 5352
AMER
+1 908 534 4445 x600
EMEA UK:
+44 161 721 5247
Switzerland:
+41 61 686 4800