Regulatory Asset Ownership & Licensing For Global Pharma Markets
Vyocure holds and licenses marketing authorisations and EU CTD regulatory dossiers across key therapeutic areas, supporting Pharmaceutical companies, institutional supply and international tenders across multiple global markets. Select assets are available with established GMP manufacturing and finished-product supply
Vyocure also operates a dedicated digital regulatory documentation platform, providing downloadable, standardised documentation frameworks supporting regulatory affairs operations and quality system compliance.
CURRENT OPPORTUNITY: Ceftriaxone Injection 1 g & 2 g — UK Marketing Authorisation available for international licensing and tender supply. Open territories. Established GMP manufacturing, with validated supply chain and quality control.
This asset is available with a complete technical package and defined commercial models, including product supply, out-licensing, duplicate MA, and hybrid arrangements, enabling flexible engagement aligned with partner and market requirements.
Regulatory Documentation Store - PharmDocs Store – Templates for Pharma Compliance
Access ready-to-use regulatory documentation templates designed for pharma operations.
SOPs, QMS systems, validation protocols, checklists and more — all available for immediate download.
Regulatory Assets & Commercial Engagement Models
Vyocure operates as a regulatory asset holder and licensing platform, enabling pharmaceutical partners to access marketing authorisations, EU CTD dossiers, and defined commercial engagement models for institutional and international markets with qualified GMP manufacturing and supply frameworks.
Dossier Development & Sales
Access our extensive library of pharmaceutical dossiers—saving you critical development time and resources.
Marketing Authorisation Transfer
Regulatory Documentation Templates & Forms
Structured regulatory documentation frameworks supporting internal implementation, due diligence processes, and commercial regulatory transactions.
Supply Management
Dossiers with Exclusive Offers
Explore our spotlight selection of high-demand pharmaceutical dossiers—ready for licensing and tailored to strategic market needs.
Diclofenac Gel
- Strengths: 1% and 5%
- Therapeutic Area: Topical anti-inflammatory
Piperacillin Tazobactam
- Strength: 4.0g / 0.25g vial
- Therapeutic Area: Broad-spectrum antibiotic injection
Cefuroxime Injection
- Strengths: 0.25g / 0.75g / 1.5g
- Therapeutic Area: Cephalosporin antibiotic
Meropenem Injection
- Strengths: 0.5g / 1.0g
- Therapeutic Area: Carbapenem antibiotic
Irinotecan Injection
- Strength: 20 mg/ml
- Therapeutic Area: Oncology / Chemotherapy
Enalapril Tablets
- Strengths: 2.5 / 5 / 10 mg
- Therapeutic Area: ACE Inhibitor for hypertension
Atorvastatin Tablets
- Strengths: 10 / 20 / 30 / 40 / 60 / 80 mg
- Therapeutic Area: Cholesterol-lowering agent
Aspirin Paracetamol Caffeine Tablets
- Strengths: Combination
Note: (now bibliographic EU application)
Azithromycin Tablets
- Strengths: 250 mg & 500 mg
- Therapeutic Area: Macrolide antibiotic
Ceftriaxone Injection
- Strengths: 1.0g / 2.0g
- Therapeutic Area: Cephalosporin antibiotic
Ceftazidime Injection
- Strengths: 0.5g / 1.0g / 2.0g
- Therapeutic Area: Cephalosporin antibiotic
Regulatory Capability Within an Asset-Led Model
Regulatory capability at Vyocure exists to support the ownership, maintenance, and commercialisation of regulatory assets. It underpins portfolio strategy, partner engagement, and transaction readiness across international markets, and is applied within a defined, partner-executed operating model.
1. Regulatory Strategy & Asset Governance
2. Submission Scope Definition & Partner Coordination
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.