Our expertise
Consulting and hands-on support. Trials, manufacturing and analyses are carried out by our clients’ sites or subcontractors, whom we help select and manage.
Pipeline and new products
Building the portfolio, from repurposing to innovation.
- Screening: repurposing of human molecules, generics and hybrids, essential veterinary medicines
- New products: target product profile, dosage form and strength, positioning
- Non-clinical and clinical programmes designed with our experts; EU and US (FDA) strategy
Due diligence and partnerships
Assessing assets and partners, then preparing the agreements.
- Technical and regulatory due diligence, including reuse of human dossiers
- IP and licensing terms reviewed with our specialised advisers
- Licensing, co-development, supply and quality agreements
Formulation
Dosage forms suited to the target species, through to technology transfer.
- Oral (palatable, scored tablets, pastes), topical, liquid and ophthalmic forms
- Complementary feed formulation
- Stability programmes and specifications (VICH GL3, Ph. Eur.)
Veterinary regulatory
Choosing the route and preparing dossiers under Regulation (EU) 2019/6.
- Well-established use, limited markets, national, decentralised or centralised procedures
- Gap analyses, literature reviews, Part 2 (quality) in VNeeS format
- EMA procedures: SPOR, IRIS, SME status, limited market classification
Animal nutrition
Built on our own experience as a registered feed business operator.
- Qualification: feed material, complementary feed or additive
- EU Catalogue and Register of feed materials, labelling and claims
- Registration, HACCP, traceability and recall procedures
Organisation and projects
Setting up what a project needs, and steering it.
- Quality systems and establishment authorisations (Swissmedic, EU authorities)
- Selection and coordination of providers: MAHs, pharmacovigilance, CROs
- Timelines, budgets and steering reports
How we work
- 1
Screening
Prioritise opportunities
- 2
Due diligence
Go / no-go
- 3
Strategy
Profile, route, plan
- 4
Development and dossier
With your partners
- 5
Submission
And follow-up with authorities
You can entrust us with one step or the whole journey. You stay in control of your decisions and submissions.
Tell us about your project.
A focused conversation is the first step.