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.

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

Leverage our active marketing authorisations with supply agreements to fast-track your market presence.

Regulatory Documentation Templates & Forms

Structured regulatory documentation frameworks supporting internal implementation, due diligence processes, and commercial regulatory transactions.

Supply Management

Ensure consistent product quality and uninterrupted supply through our integrated oversight of manufacturing, logistics, and QA processes.

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

Regulatory strategy is applied at asset level to define appropriate development pathways, licensing structures, and partner engagement models in alignment with target markets.

2. Submission Scope Definition & Partner Coordination

Regulatory submission activities are scoped, structured, and coordinated with qualified third-party partners as part of asset development and lifecycle planning.

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.