What we do
Clinical Studies
We perform clinical investigations and can support you with clinical investigations and developmental stage and type of design.
Regulatory Affairs
We support you in handling challenges and questions arising throughout your medical device life cycle and navigate regulatory requirements.
Lab Services
In our facility, we perform tailored lab service for clinical studies and your product development phases.
About us
Astris Biotech is a regulatory consulting company in Sweden.
We support you throughout the life cycle of your medical device and In Vitro Diagnostic (IVD). Our advice is always founded on our vast experience, you get the inside perspective..
- With extensive medical device and IVD experience within Quality, Regulatory and Clinical Affairs, and a team of experts on staff, we provide full service solutions to our clients – from idea to market.
- We have the experts in international working groups writing medical device and IVD standards, we provide our clients with an industry perspective and first-hand advice.
- Together we offer unique expertise regarding Strategy, Quality Assurance, Regulatory Affairs, Clinical Affairs and Biocompatibility from a group of partner companies, working as one.
- By multiple clincial study sites, We provide customized solutions, not a one-size-fits-all. We can take care of your complete clinical program from A to Z or support you with very specific tasks within your clinical trials.
Our partners
Contact
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Write to us
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