Neva applies applicable Good Manufacturing Practices when specified by the client to perform GMP services. Neva has the analytical capability to support characterization and specification testing across a range of medicinal products and materials including biologics, small molecules, gene therapy components and combination products from both GMP and non-GMP (R&D) processing and development scenarios.

As you focus on your core business activities, developing and evolving your intellectual property and its supporting data package, all of your outsourced partners need to have extensive experience knowing where they fit into your product’s development scheme. Then they need to deliver results which meet applicable pharmaceutical regulatory data integrity and reliability expectations.

Neva is FDA registered for analytical services, which means it can uniquely support your program from the earliest R&D activities all the way through into commercialization – without the need for clients to plan and pay for multiple tech transfers over a product’s life-cycle. Neva applies general Quality Management Principles to all key operations to support the delivery of reliable data regardless of its R&D or GMP designation.

We provide characterization and/or specification testing for active pharmaceutical ingredients (APIs), intermediates, investigational medicinal products (IMPs) or finished products with Marketing Authorizations.

Neva also supports a range of non-GMP (R&D) analytical needs including method development and method qualification for biotech/pharmaceuticals products and raw materials, as well as a variety of characterization testing on intermediates. Starting with a middle ground perspective, we work with clients to understand their analytical needs and leverage our experience to tailor a solution that precisely meets quality, compliance and efficiency requirements in a ‘not too much, not too little’ approach.

Test Methods & Turn Around Times

Client-specific custom methods,
Neva platform methods, USP
compendial methods and basic
wet chemistry analyses

After method set-up and/or verification is
complete, routine samples are typically
analyzed within 2-14 days of receipt –
based on the assay