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:

1

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. 

 

 

5

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.

 

dizajn

Blister and outer packaging design and development

Creating a unique design for your brand, as well as developing a rigid blister package design.

 

pomosch-v-prohozhdenii-go

Assistance in passing the State registration

Consulting services on the procedure of medical devices state registration, as well as the development of regulatory documents.

 

iso13485

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.

 

validaciya-processov

Validation of production processes

Validation of sterilization processes service, and aseptic filling.

 

 

6

Laboratory research

Testing of products according to such indicators like: bacterial endotoxins, bioburden, pH level, viscosity, sterility, vial / syringe tightness.

© «Sigma Lab», 2020