NDA Analytics is a single site facility located in rural Cambridgeshire. We have been providing cGMP analytical development, lot release and stability testing services to the pharmaceutical and biopharmaceutical industry for over twenty years.

Our staff include leading industry experts, senior scientists and a team of highly skilled technicians. Add first rate laboratories equipped with latest technologies and we can offer you a world class solution.

This mix of experience and expertise has helped to successfully guide numerous biologic products through development and on to the market.  These include recombinant proteins, monoclonal antibodies, peptides, enzymes, vaccines, DNA vaccines, gene therapies and oligonucleotides.

Specialist fields

A key aspect of our expertise is the provision of in vivo and in vitro cell based bioassays and biological binding assays delivered according to cGMP.  This is of particular benefit to our customers whose biologics lot release packages usually contain at least one potency assay.

We provide Quality Control (QC) lot release testing for biological products destined for market and the clinic. 

Regulations

NDA Analytics is regularly inspected by both MHRA and FDA in respect of our GMP lot release testing services.  Whether your product is licensed and destined for market, or is an investigational medicine for use in clinical trials, we can provide a responsive and reliable testing service.  We understand the business-critical nature of the product supply line and the part that QC testing plays in that process.

Wide range of services

We offer drug substance and final drug product stability testing and storage services to support your regulatory dossiers throughout the development process.  This includes stability studies to support clinical trial applications (CTA, IND), product license applications (MAA, NDA, BLA) and stress testing (degradation studies).  Our controlled-environment walk-in rooms and reach-in cabinets cover all standard ICH and WHO conditions, providing world-wide dossier support.

We have expertise in a wide range of physicochemical and biological techniques to assess the identity, structure, sequence, purity, shape, concentration, size, appearance, conformation, activity and particulate nature of your product. 

Our experience in method development, transfer, validation and troubleshooting ensures a smooth and efficient business relationship.

Integrated strategy

NDA Analytics offers integrated development strategies to help drive products through development and onto the market, providing effective communication via dedicated project managers to keep customers continually updated and help deliver to their exact requirements.  Flexibility to meet your requirements is paramount; we provide results how and when you want them.