Analytical Development
Get stage-appropriate methods that evolve with your formulation and process
Build the analytical foundation your CMC package needs, with method development for assay, degradants, antioxidants, and preservatives, VICH-aligned stability programmes, and in-process testing from a team with more than 20 years of animal health experience.
Talk to our analytical scientists
Every method is designed with your end submission in mind and developed in tandem with your formulation and process.
“Their analytical expertise is second to none. They have a lot of expertise, a lot of depth.”
—Tammy Newbold, CMC consultant
33 full-time QC scientists in Auckland
2 development sites with analytical laboratories
330+ SKUs transferred with dossier development
Our Analytical Development Services
Get methods for identification, assay, impurities, degradants, dissolution, and content uniformity, designed from the start to support your regulatory submission.
Detect and quantify degradation products with forced degradation studies and stability-indicating methods that support shelf-life determination and specification setting.
Get analytical support for raw material testing, in-process controls, and finished product release.
Set specifications, characterise your product, and answer regulatory and funding questions with informational data captured during GMP runs.
Confirm identity, assay, impurities, and residual solvents for every dosage form, with HPLC (DAD and VWD), UPLC, and GC headspace analysis.
Show that your oral solids, soft chews, and pastes release as intended, with discriminatory dissolution methods built for each format.
Make sure your semi-solids and pastes flow, spread, and dose consistently from batch to batch.
Keep the texture of your soft chews and semi-solids consistent, so your product handles and doses the same way every time.
Control particle size in your suspensions and microspheres with laser light scattering (Malvern Mastersizer 2000) and dynamic light scattering.
Find out whether your suspensions and emulsions will stay evenly dispersed through their shelf life.
Measure how well your transdermal solutions and spot-on products permeate the skin.
Support your shelf-life claims for every dosage form with stability studies run in our own chambers.
Your early-phase work runs alongside pilot, feasibility, and target-animal safety studies, so formulation data shapes your study design, and study results feed back into your formulation decisions.
Why Argenta
Your methods are stage-appropriate, so you’re not over-investing early and you’re ready for validation when you need to be.
Your analytical development flows directly into process validation and commercial release testing, with no method transfers between organisations.
