Medis
Out-licensing specialist for generic pharmaceuticals since 1985. Maintains an extensive portfolio of solid oral dosage forms, parenteral products and other dosage forms; provides in-house product development and analytical support, regulatory dossier preparation and submissions, serialization and track-and-trace implementation, and coordinated supply chain and product launch services for licensees and distributors.
Industries
Nr. of Employees
medium (51-250)
Products
Abiraterone (film-coated tablet, 500 mg)
Antineoplastic agent listed as an available film-coated tablet formulation (500 mg).
Alectinib (hard capsule, 150 mg)
Antineoplastic agent listed as a hard capsule formulation (150 mg) and indicated as under development.
Abiraterone (film-coated tablet, 500 mg)
Antineoplastic agent listed as an available film-coated tablet formulation (500 mg).
Alectinib (hard capsule, 150 mg)
Antineoplastic agent listed as a hard capsule formulation (150 mg) and indicated as under development.
Services
Licensing of registration dossiers and finished pharmaceutical products to third-party companies, with commercial, regulatory and lifecycle support.
Regulatory strategy development, dossier gap analysis, CTD dossier preparation, EU variation packages and ongoing lifecycle management for multiple territories.
Technical implementation and operational support for serialization requirements, IT connectivity, barcode/data matrix integration and maintenance of serialization master data.
24/7 portal for order placement, order history, KPI dashboards, document downloads and integration with resource planning systems.
Licensing of registration dossiers and finished pharmaceutical products to third-party companies, with commercial, regulatory and lifecycle support.
Regulatory strategy development, dossier gap analysis, CTD dossier preparation, EU variation packages and ongoing lifecycle management for multiple territories.
Technical implementation and operational support for serialization requirements, IT connectivity, barcode/data matrix integration and maintenance of serialization master data.
24/7 portal for order placement, order history, KPI dashboards, document downloads and integration with resource planning systems.
Expertise Areas
- Out-licensing and commercialization of generics
- Regulatory strategy and CTD dossier preparation
- Generic formulation and parenteral formulation development
- Analytical method development and stability testing
Key Technologies
- Common Technical Document (CTD) dossiers
- Serialization and 2D data-matrix track-and-trace systems
- Cloud-based customer portals and ERP integration
- Stability testing across ICH zones
News & Updates
Website accessibility statement updated; site follows WCAG 2.1 AA guidelines and provides contact for accessibility enquiries.
Named a finalist in the CPhI 2019 Pharma Awards.
Website accessibility statement updated; site follows WCAG 2.1 AA guidelines and provides contact for accessibility enquiries.
Named a finalist in the CPhI 2019 Pharma Awards.