ONIX – YOUR TRUSTED PARTNER FOR REGULATORY OPERATIONS AND eCTD SERVICES
– FROM INITIAL APPLICATION TO LIFECYCLE MAINTENANCE
ONIX Life Sciences are a boutique consultancy specialising in regulatory operations services to support clients with drug applications to the health authorities for approval and drug to market.
ONIX has built a track record of being an industry expert in global eCTD submissions. Our in-depth knowledge over 60 years of combined experience allows us to guide clients through the complex regulatory environment.
Since launching in 2010, ONIX has successfully completed drug applications for more than 100 clients globally (Europe, North America, Asia Paciﬁc, South America). All submissions completed within the client’s timeframe and NEVER had an eCTD technical rejection. Our reputation for expert knowledge, quality of service and speed is core to every engagement with all clients.
ONIX simplify the eCTD process, regulate the eCTD submission for the health authority to approve.
Simplify, Regulate, Approve
Regulatory submissions can be complex and time-consuming. We work closely with our clients, guiding them through the complex regulatory operational requirements and providing the strategic and technical advice to make the process of eCTD submissions simpler and quicker.
ONIX supports global eCTD submissions to FDA, Europe (EMA, MHRA, National Agencies), SwissMedic, Health Canada, TGA and other regulatory health authorities.
We work with our clients to establish long term relationships, based on mutual trust and benefits to become a trusted regulatory operations outsourcing partner.
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