The use of electronic Common Technical Documents or eCTDs has revolutionised regulatory procedure. Providing a vital link between organisations within the pharmaceutical sector and regulatory health authorities like the FDA and EMA, eCTD submissions offer a convenient and efficient way to submit important documentation.
Submitting an eCTD in line with the latest regulatory procedures dictated by global health agencies is a must however, and as you’ll discover, there’s a fine line between success and failure. Obtaining support from an electronic submissions service vendor will enable you to meet current requirements and understand the landscape, all of which pave the way to successful eCTD submission.
Read on to discover what you should consider when picking your perfect eCTD submission partner.
Experience
Whilst eCTDs are considered a relatively cutting-edge addition to regulatory procedure, choosing a service provider with experience across the entire spectrum of regulatory operations and eCTD services is a must.
With experience and knowledge of everything from the initial application process to lifecycle maintenance, we provide a depth of service many other providers don’t. Our team has more than 60 years of combined experience supporting Pharma, Biotech, Universities, Contract Research Organisations (CROs) and Pharma Venture Capital companies with their regulatory approval processes.
During our time within the industry, we’ve helped more than 100 clients worldwide, including organisations based in Europe, North America, South America, the Middle East and Asia Pacific.
Software
Our use of the latest software, which is designed, developed and delivered in accordance with up-to-the-minute eCTD format requirements and regulations for optimum regulatory compliance, is renowned.
From predefined eCTD Word templates to eCTD viewers, our technology aims to simplify the process, regulate submission and ensure approval. In fact, our experience and specialised software use means we’ve never had an eCTD technical rejection!
Quality
Our quality of service is something we are extremely proud of here at ONIX. Built on engagement with the client, our services ensure a reliable and reputable source of support when facing and overcoming the hurdles every organisation encounters when submitting applications to health authorities for approval or bringing a drug to market.
With an end-to-end solution coming as standard, our trusted consultants always take a tailored approach to regulatory procedure to ensure processes can be as seamless, efficient and compliant as they should be.
Speed
Without the right management and support, eCTD submissions can be particularly costly and time consuming.
Here at ONIX, we understand that time is of the essence, even in a complex and ever-changing regulatory environment. Whatever eCTD service you require, we aim to deliver your project on time, to brief and within budget.
For further information about why you should choose ONIX as your eCTD service provider or to find out more about our eCTD services, please contact us today.
