Good Manufacturing Practice (GMP) pharmaceutical batch release testing or lot release testing to help you to ensure the quality of drug products including specialised testing for inhalation products or biologic 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 a contract analytical services partner with a strong history of delivering regulatory compliant API, IMP or finished products batch release testing to a consistently high standard with responsive turnaround times.
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 or inhaled drug products, oligonucleotides and biologics (such as monoclonal antibodies, biosimilars, bispecific antibodies and viral vectors). 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.
With a long history of providing GMP batch release testing contract services, our highly skilled scientists 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. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.