Many well-known life science companies already rely on the performance of our products and services, so we decided to let them have their say. To this end, we have launched a new series of interviews in which they can tell us how they support our customers and what makes them so special.
We'll start with our Regulatory Publishing Services. In a short interview, they tell us, among other things, which tasks they cover, which projects they like to take on the most, and, of course, how their colleague eCTDmanager supports them...
Welcome, and thank you for joining us today. Could you please introduce yourself?
Greetings! It's a pleasure to meet you. I am the Regulatory Publishing Services Offer here at EXTEDO, based in the Regulatory Competence Center (RCC).
Could you describe your role and how you support EXTEDO's clients?
Certainly. My role encompasses providing a comprehensive suite of international Regulatory Publishing Services, including handling submissions in collaboration with eCTDmanager and ensuring impeccable document formatting. I manage a diverse array of submissions across multiple global regions, which encompasses both original applications and lifecycle management submissions. Additionally, I handle various other document-related tasks.
That's quite an extensive array of tasks you manage. Do you have a favorite aspect of your work, and if so, why?
Indeed, I do. I particularly enjoy the process of publishing original applications, as it involves overseeing the entire journey from inception to the final submission. This enables me to offer valuable guidance on publishing best practices while also ensuring adherence to the specific eCTD guidelines for different regions and health authorities. I have gathered a lot of expertise in these guidelines, which is invaluable for the success of a project.
If someone wanted to become an expert in submission publishing like you, could you assist with their journey?
Absolutely, I'd be delighted to help. I can provide training sessions tailored to different levels, starting with eCTD basics and progressing to in-depth training for those aspiring to become submission publishing experts.
Your close collaborator, eCTDmanager, plays a significant role in your work. Could you elaborate on your partnership with them?
Certainly, eCTDmanager is an invaluable colleague. They assist me in maintaining a keen eye on quality control, highlighting where I excel and where improvements are needed. This extends to aspects like document naming and the correct creation of STFs. They also identify and address broken hyperlinks and help me pinpoint issues before submission to regulatory authorities. In essence, eCTDmanager is a trusted friend and a crucial part of my success.
Is there anything else our readers should know to understand your capabilities better?
Indeed, I am a highly versatile service offer. Beyond publishing services, I also offer regulatory consulting and regulatory intelligence services. I'm here to assist both existing and new clients, ensuring prompt and efficient service delivery in collaboration with eCTDmanager. Additionally, I'm available to support clients throughout the day, covering 14 hours in both European and US time zones.
How can those interested in working with you get in touch?
The most convenient way to reach out to me is through your dedicated account manager if you have one. Alternatively, you can contact me via the EXTEDO website on my page: https://www.extedo.com/services/regulatory-publishing-services. Simply complete the provided form and include a brief description of your specific challenges. I'll promptly send you a dedicated form for publishing requests, and we can schedule a call to discuss your unique needs.
We appreciate your time in sharing these insights - a truly informative and engaging conversation. Thank you!
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