Early Phase Development

Early phase drug development

Choose your strongest candidate before you commit to full development

Get the phase-appropriate formulation, analytical, and stability data you need to lock your formulation and process, with early phase development services that run alongside your first target animal studies and build toward registration from day one.

Talk to our development scientists

Start full development with your risks known and your data in hand

Our scientists take a feasibility-first approach that surfaces risk early and builds toward registration from day one.

Know your long-term risks upfront: A multidisciplinary team evaluates your API’s physicochemical properties, species-specific dosage form options (including palatability where applicable), and manufacturability, then identifies long-term risks before you commit resources.
Base your formulation on solid API data: Preformulation profiling covers particle size, density, flow properties, solubility, polymorphism, hygroscopicity, and excipient compatibility, providing the foundation your formulation development depends on.
Narrow down to your strongest candidate: Iterate rapidly at a small scale across oral solids, soft chews, non-sterile liquids, controlled-release systems, and topicals before process development begins.
Run analytical and stability work alongside formulation: Fit-for-purpose methods and VICH-aligned stability programmes are built with your INAD submission and eventual registration in mind.
Submit with confidence: CMC source documents and technical sections for INAD submissions, MUMS designation applications, and pre-NADA packages are written by scientists who understand FDA CVM and EMA expectations.

Talk to our development scientists

200+ projects supported through to registered products

20+ years of animal health-specific expertise

100+ veterinarians and clinical trial staff

Our Early Phase Development Services

Early phase drug development services that get you to your first study

Move from concept feasibility to clinic-ready CMC with early phase drug development services designed to de-risk your programme.

Feasibility assessment

Get clear recommendations for a development pathway before you commit. We assess your API, target species requirements, dosage form options, and development risk profile.

Preformulation & API characterisation

Get the dataset behind every downstream formulation and process decision, from solubility and particle size distribution to polymorphic form and excipient compatibility.

Prototype development & screening

Choose your go-forward formulation with confidence. We prototype rapidly at a small scale, screening for physical stability, dissolution where relevant, and palatability where applicable.

Early stability programmes

Support preliminary shelf-life claims, specification setting, and packaging selection with VICH-aligned stability studies designed for INAD-stage submissions.

Clinical trial supplies

Supply your preclinical and clinical studies with material made at the bench on a pilot scale.

Regulatory-ready CMC documentation

Get CMC source documents and technical sections prepared for INAD submissions, MUMS designation applications, and pre-NADA packages.

Talk to our development scientists

Dosage Forms

Get early phase support for every animal health dosage form

Work with formulation scientists who have developed and scaled each of these formats for animal health registration.

Oral solids

Soft chews

Non-sterile liquids

Suspensions

Controlled-release capsules

Microspheres

Spot-on tubes

Transdermal solutions

Sterile injectables

Explore dosage forms

Take your product from molecule to market with integrated services

Early phase development

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.

Formulation development

Your regulatory team works alongside your formulation scientists from day one, so every formulation decision supports your submission.

Analytical development

Your analytical work spans product optimisation through registration, so the methods you develop early carry through to your dossier.

Process development

Your pilot and registration batches supply your field studies directly, so test articles never move between partners.

Explore pharmaceutical development Explore the full molecule to market story

Why Argenta

Why choose Argenta for early phase development?

De-risk before you commit

Identify formulation, API, and manufacturing risks before you choose a development path or pay for pivotal studies that your formulation isn’t ready to support.

Work with animal health formulation scientists

Draw on palatability expertise for companion animal oral products, preservative expertise for multi-dose livestock presentations, and know-how in our proprietary delivery platforms.

Build for INAD, scale for NADA

Your data package is structured with your INAD submission and eventual NADA in mind, so proof-of-concept data still supports your registration filing years later.

Related Services

Pre-clinical studies

Run pilot, pharmacokinetic, and challenge studies in your target species in our own AAALAC-accredited facilities, with early data feeding straight into your formulation decisions.

Learn more

Clinical studies

Run your target animal safety studies alongside your early phase work, with VICH-GCP-compliant studies designed by animal health regulatory experts.

Learn more

Regulatory affairs

Get regulatory strategy and gap analysis before development begins, so your formulation work starts with a clear path to registration.

Learn more

Featured Resources

Free fact sheet: Argenta's soft chew technology for animal health products

Download Argenta's soft chew fact sheet to discover the extrusion methodology behind the technology, how it enhances palatability, detailed dissolution information, and how API stability is preserved throughout manufacturing.

Download Your Fact Sheet

eBook: Developing a palatable and effective soft chew for companion animal medicine

Explore the benefits of soft chew technology, the common barriers to creating an effective product, and the strategies to overcome them for a faster, de-risked route to market.

Download the eBook

Drug Delivery Technologies

From palatable soft chews to controlled-release microspheres, discover Argenta's five proprietary, licensable technologies developed exclusively for veterinary applications.

Explore Our Technologies

Explore all resources

FAQs

Can you help a startup with a promising molecule but no formulation capability?

Yes. We help early-stage companies take a molecule to market, starting with feasibility studies, funding-ready data packages, and regulatory strategy. You speak directly with the scientists doing the work.

What does an early-phase drug development feasibility assessment include?

API characterisation and stability risk, excipient compatibility, dissolution and release profile feasibility, preservative system compatibility, manufacturability and scale-up, regulatory pathway alignment, and palatability, where applicable.

Can you supply material for our preclinical and clinical studies?

Yes. Our clinical trial supplies team manufactures batches in our FDA/EMA-approved animal health facilities for target animal safety, PK, and proof-of-concept studies.

How does early phase development connect to clinical studies at Argenta?

Your CMC and clinical teams work together from day one, so your studies use material made by scientists who know your formulation. Studies that run alongside early-phase development include target animal safety (TAS), proof-of-concept pharmacokinetic (PK), bioequivalence (BEQ), palatability for companion animal oral products, challenge model efficacy in companion and livestock animals, and margin of safety with formulated product.

Which regulatory authorities do you work with?

FDA CVM, EMA, APVMA, and EFSA. Your CMC strategy is VICH-aligned for global registration from day one, which makes entering a second market easier.

Can you give a ballpark estimate before we have a full technical package?

Yes. We can scope your project from limited information and give you realistic early timelines and cost estimates for investor pitches and funding applications, then refine them as your project develops.

Healthy Animals. Let’s Make It Happen, Together.

Get the feasibility data and clinic-ready CMC package you need to de-risk your animal health product and speed your route to clinic.

Talk to our development scientists

The difficulties of de-risking development

Comprehensive early development is essential to proactively eliminate risk and plot an optimal route forward for your product.

However, it…

Requires advanced technical capabilities

Thoroughly exploring your product’s risk space can be technically demanding. Having the right tools to hand, and knowing how and when to apply each, is paramount for success.

Demands significant expertise

Balancing risk and cost in early development is key to successful progression of your product. But knowing what to do — and how best to do it — hinges on a breadth and depth of expertise that few companies possess.

Can be costly if not done right

Without thoroughly reviewing risk and testing outcomes on a smaller scale before progressing with full product development, you could end up wasting significant time and resources, or even risk late-stage programme failure.

Contact our experts today

The expertise and technical capabilities you need

With 200+ years of collective experience in bringing innovative animal health products to market, we have the know-how and capabilities to conduct comprehensive early development activities — giving you the confidence needed to progress to the clinic.

Thorough risk assessment

Our expert multidisciplinary team will comprehensively explore and quantify your product’s risks, including any technical and scientific limitations. Armed with this knowledge, they help you identify the best development route for product success.

Building a robust dataset

We’ll produce the high-quality data you need to make critical go/no-go decisions. And we’ll do it in the most efficient way possible, making the best use of your valuable time and resources.

Product optimisation

Using data-driven insights, we’ll enhance your product, optimising its performance and finding the most cost-effective manufacturing process, all while ensuring it meets complex regulatory requirements.

Connect with our early development experts

Progress your product with confidence. Let’s make it happen, together.

Want to de-risk and advance your animal healthcare product programme?
Reach out to our experts today to discuss how our early development services can mitigate risks early, and help you take a more confident step into clinical development.

A solution for every step of the way

Early development is only one step to successful product actualisation. But wherever you are in your product development journey, Argenta can help.

Discover our full range of ‘molecule to market’ services:

Healthy Animals. Let's Make It Happen, Together.

Newsletter Sign-Up

Keep up to date with the latest news from Argenta