CTD-Dossiers
Vyocure maintains a portfolio of EU CTD–formatted pharmaceutical dossiers developed to established regulatory standards and structured for licensing and territorial registration activities. These assets have supported regulatory engagements across multiple international markets and are made available for evaluation and partner-led registration strategies.
What We Offer
- 200+ dossiers across key therapy areas and dosage forms
- Used successfully in EMA, FDA, MHRA
- Stability studies
- Full CMC documentation
- Clinical data packages
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
Dosage Form
- Oral Solids (tablets, capsules)
- Injectables
- Topicals
- Modified Release Systems
- Inhalation Products
- Ophthalmic Preparations
All our dossiers have been used for successful registration
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 UK
market - Structured MA Transfer Framework: Structured MA Transfer Framework: MA transfer processes are defined at asset level and executed through qualified third-party partners in accordance with applicable regulatory requirements.
- 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, we are here to assist.