Product development

Our role

Turning concepts into compliant, market-ready products

Product development in veterinary pharmaceuticals requires deep scientific expertise combined with a thorough understanding of regulatory expectations. Regivet bridges both — ensuring your formulation is not only technically robust but also submission-ready.

We work across all major dosage forms and species, supporting both new active substances and generic/hybrid applications.

All dosage forms and species

VICH and ICH compliant

New substances and generics

Submission-ready dossiers

What's included

Development services in detail

Feasibility & target product profile

Early-stage assessment of technical and regulatory feasibility, including target product profile definition and route-to-market strategy.

Market and regulatory landscape review
Target product profile (TPP)
Technology and formulation options
CMO/CRO landscape mapping

Formulation development

Development of pharmaceutical formulations optimised for efficacy, stability and manufacturability — across all relevant dosage forms.

Pre-formulation studies
Formulation optimisation
Compatibility studies
Prototype manufacturing and assessment

Analytical development & validation

Development and full ICH/Ph.Eur. validation of analytical methods for identity, assay, impurities and dissolution.

Method development (HPLC, GC, UV)
Method transfer and co-validation
Validation to ICH Q2(R1)
Reference standard qualification

Stability studies

VICH and ICH-compliant stability programs, from protocol design through final report and shelf-life justification.

Long-term and accelerated studies
Photo-stability (ICH Q1B)
Freeze-thaw and in-use studies
Shelf-life determination

CMO/CRO selection & management

Identification, qualification and ongoing management of contract manufacturers and research organisations best suited to your project.

CMO/CRO identification and shortlisting
Qualification audits
Technical agreements and oversight
Project management and reporting

Scale-up & tech transfer

Structured technology transfer from development scale to commercial manufacturing, ensuring reproducibility and GMP compliance.

Process development and optimisation
Scale-up batch manufacturing
Tech transfer documentation
Validation support