Romanya İlaç ve Biyoteknoloji Şirketi Laboratuvar Genişlemesi İçin Yatırım ve GMP Ortaklığı Arıyor

Romanyalı bir ilaç ve biyoteknoloji şirketi, Romanya'daki laboratuvar ve üretim yeteneklerini genişletmek için AB merkezli bir stratejik ortak arıyor. Ortaklık, mevcut ekipmanları, ilaç bilgisi, özel formülasyonları, tescilli markaları ve izlenebilirlik teknolojisini GMP uzmanlığı, düzenleyici yetenekler, üretim altyapısı ve yatırımla birleştirecektir. Önerilen işbirliği, bir yatırım anlaşması aracılığıyla yapılandırılacaktır.

A Romanian pharmaceutical and biotechnology company is seeking an experienced European strategic partner to support the expansion of its laboratory and manufacturing capabilities in Romania. The cooperation will focus primarily on OTC pharmaceutical products and/or medical devices, while remaining open to selected biotechnology and bioprocessing applications. The company brings practical know-how in pharmaceutical product development, biotechnology, laboratory processes and production-related activities, together with existing laboratory and pilot-scale equipment, formulations, registered trademarks, proprietary software and technical expertise. Its infrastructure includes bioreactors, incubators, biological safety equipment, centrifuges, -80°C storage, rotary evaporators, homogenisation equipment, mixers, pumps and semi-automated packaging systems, providing a solid basis for development, process optimisation and scale-up. An additional strategic asset is proprietary software designed for pharmaceutical and laboratory workflows, with applications in traceability, production records, inventory management, process monitoring and related documentation. The company is seeking an EU-based partner with GMP manufacturing and regulatory capabilities, or proven expertise in establishing and operating an appropriately authorised manufacturing framework. Experience in pharmaceutical/OTC manufacturing, medical devices, quality systems, validation, technology transfer and EU regulatory affairs would be highly valuable. The partnership would combine the Romanian company's equipment, formulations, trademarks, know-how, software and local capabilities with the partner's GMP expertise, regulatory capabilities, qualified personnel, manufacturing infrastructure and potential financial investment. The long-term objective is to establish a commercially viable, appropriately authorised development and manufacturing operation in Romania, serving the Romanian and wider EU markets. The cooperation is envisaged through an investment agreement, with the investment structure, product portfolio and regulatory pathway to be agreed with the selected partner.

The partner is expected to provide the regulatory, manufacturing and industrial capabilities required to transform the Romanian company's existing technical and intellectual assets into an appropriately authorised commercial operation. Depending on the selected project, the partner would contribute GMP-certified manufacturing premises or access to suitable GMP infrastructure, quality and validation systems, regulatory expertise, qualified personnel, technology-transfer capabilities and manufacturing know-how. A key part of the cooperation would be the joint definition and implementation of the appropriate regulatory pathway, including quality requirements, process validation, equipment qualification, documentation and the authorisations required for the selected pharmaceutical, OTC and/or medical device activities. The partner may also contribute additional production equipment, technology, formulations, products or manufacturing know-how that complement the company's existing capabilities. Financial investment may form part of the cooperation, but contributions in the form of GMP infrastructure, equipment, technology, regulatory resources and manufacturing capacity would also be considered. The Romanian company would contribute its existing laboratory and bioprocessing equipment, technical infrastructure, pharmaceutical and biotechnology know-how, formulations, registered trademarks, proprietary traceability/process-management software and local operational capabilities. The parties would jointly identify and develop selected products or technologies, with potential cooperation covering technology transfer, product development, process optimisation, scale-up, validation, authorised manufacturing, packaging and commercialisation in Romania and other EU markets. The preferred partner should be willing to participate actively in establishing the technical, regulatory and commercial framework, rather than acting solely as a financial investor. The investment structure, responsibilities, ownership arrangements, product portfolio and commercial model would be agreed based on the selected project and the partner's capabilities.