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Services
We are ready to accompany you at all stages of introducing a product into production: from an idea to registration and release to the market. Our company provides the following services:
Contract manufacturing of medical devices
Filling of biopolymer compositions into pre-filled syringes, as well as into vials. Lyophilization services for thermolabile substances, packaging and labeling of finished products.
Development, prototyping and production of biopolymer compositions a pilot series
Doing research and development work (R&D) in the direction of biopolymer compositions for medical use.
Blister and outer packaging design and development
Creating a unique design for your brand, as well as developing a rigid blister package design.
Assistance in passing the State registration
Consulting services on the procedure of medical devices state registration, as well as the development of regulatory documents.
Development of documents according to the Quality Management System
Consulting on certification requirements and the required set of documents, assistance in the development and implementation of the QMS.
Validation of production processes
Validation of sterilization processes service, and aseptic filling.
Laboratory research
Testing of products according to such indicators like: bacterial endotoxins, bioburden, pH level, viscosity, sterility, vial / syringe tightness.
