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.
Regulatory submission management can be a complex process, we take the complex and make it simple. We wholly manage the eCTD process, maintaining a complete overview of the submission across multiple lifecycle stages and to global regulatory health authorities.
Our consulting team is on hand to provide our client best practice advice within regulatory operations to ensure that they are set up for success with their submission and ongoing lifecycle maintenance. We optimise, improve and reform processes to help bring clients up to speed.
To successfully meet electronic eCTD submission requirements, documents need to be compliant. ONIX undertake formatting of MS Word document and process the PDF documents ready for eCTD submission.
Drive efficiency with predefined eCTD Word templates to enable the submission management journey. We help to remove the uncertainty in formatting so clients can concentrate on content writing and not on the formatting.
Beyond Submission Management ONIX have built a network of trusted consultants and CROs to provide value across Regulatory Affairs - Writing and Management, CMC, Clinical and Non-Clinical.
We work with our clients to establish long term relationships, based on mutual trust and benefits to become a trusted regulatory operations outsourcing partner.
The timelines for preparing and submitting the applications were short and even though the work has been intense, I have been impressed and reassured by the proactivity in planning.
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