CTD-Compliant Dossiers - Ready for Registration
Vyocure offers a comprehensive portfolio of fully developed, CTD-formatted pharmaceutical dossiers—used successfully in registrations across EMA, FDA, MHRA and across numerous global markets. Our solutions are designed to accelerate your registration timelines and reduce development costs, enabling faster market access across both regulated and emerging regions.
What We Offer
- 200+ dossiers across key therapy areas and dosage forms
- Used successfully in EMA, FDA, MHRA and 100+ countries
- Peer-reviewed data
- Stability studies
- Full CMC documentation
- Clinical data packages
- Risk management plans
Our Dossier Portfolio
With over 200 pharmaceutical dossiers spanning multiple therapeutic areas and dosage forms, we offer one of the most comprehensive
portfolios in the industry.
Therapeutic Coverage
- Cardiovascular
- Respiratory
- Central Nervous System
- Oncology
- Anti-infectives
- Metabolic Disorders
And many more
Dosage Form
- Oral Solids (tablets, capsules)
- Injectables
- Topicals
- Modified Release Systems
- Inhalation Products
- Ophthalmic Preparations
Documentation Quality
- CTD-compliant
- Peer-reviewed data
- Comprehensive stability studies
- Complete CMC documentation
- Clinical data packages
- Risk management plans
All our dossiers have been used for successful registration
Request access to our dossier portfolio or speak with a dossier specialist
Marketing Authorisations with Supply Agreements
Fast-track your market entry with active marketing authorisations linked to trusted manufacturing partners and transparent regulatory histories.
- EU Approvals: Covering pan-European authorisations
- UK MHRA Authorisations: Coverage for the post-Brexit British
market - US FDA Approvals: Strategic access to the world’s largest
pharmaceutical market - Seamless Transfer Process: Our regulatory experts handle all
aspects of MA transfer - Supply Security: Established manufacturing relationships and
quality agreements
Looking for a specific dossier?
Our dossier portfolio includes over 200 CTD-formatted dossiers across all major therapeutic areas and dosage forms. If you're searching for a specific product or need tailored documentation, our regulatory team is here to assist.