SIMPLIFYING THE COMPLEX
Simplify, Regulate, Approve
ONIX is a global regulatory operations and advice consulting group. The team has over 60 years of experience in supporting Pharma, Biotech, Universities, Contract Research Organisation (CRO) and Pharma Venture Capital companies throughout the regulatory approval processes for drugs, herbal, veterinary and medical devices with their respective Regulatory Health Authorities. ONIX has supported more than 100 clients across Europe, North America, South America, Middle East and Asia Pacific throughout the process from initial clinical trials application to full marketing approvals and lifecycle maintenance.
ONIX has built a strong reputation as an industry expert in global eCTD submissions and provides Regulatory Affairs services together with our trusted network of consultants. We provide a tailored approach to every client to complement their internal processes and become an embedded extension to our client’s Regulatory Affairs team. By operating in this way, the regulatory process remain seamless and efficient. ONIX remains on-hand to take ownership of the full end-to-end eCTD submission process and act as a trusted advisor to support on regulatory operations and industry updates.
ONIX provides the expert knowledge, quality of service and speed to guide our clients through the complex, ever-changing regulatory environment across different markets and regions – to always deliver the project on time and having never had a technical rejection.
WE HAVE A 100% eCTD TECHNICAL APPROVAL RATE
The in-depth knowledge and experience of the ONIX team enables us to advise our clients on best practises and regulatory developments, avoiding common mistakes and supporting our clients in positioning the submissions in the optimum way to ensure the approval process is successful and without any delays. ONIX is proud of our 100% success rate in never having an eCTD technical rejection since inception in 2010.
COMMITTED TO YOUR GOALS
The ONIX team are accustomed to working closely with our clients to develop bespoke frameworks for seamless eCTD submission processes over time – essentially acting as an extension to our client’s team.
A GLOBAL REACH
With offices and a team based in the UK, USA and India, ONIX is well-positioned to serve the eCTD needs of our clients globally.
DELIVERING eCTD SUBMISSIONS ON TIME, EVERY TIME
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