Guest Speakers: Satish Tadikonda, President, Virtify Inc. and Ikram Baig, Chief Technology Officer, Virtify, Inc.
Life Sciences companies often experience lengthy approval delays as they bring new products to market. Today, a submissions preparation often involves a manual, paper-based process to multiple regulatory bodies where managing the lifecycle, tracking changes, assembling and submitting the right data can be a challenge. Whether you are managing NDAs, ANDAs, INDs, BLAs, MAA and other submissions, you need all the elements of the lifecycle as part of your eCTD or non-eCTD electronic submission (NEES). Companies need to put the focus where it belongs - squarely on delivering final submissions that can handle the complex, ever-evolving landscape of the Life Sciences industry. Documents for submission are constantly under review, endlessly annotated and continuously being "revised." These revisions must not corrupt the perfection of the submission, which is often the result of post-production rendering and conversion where critical errors are made or repeated resulting in delayed approvals and lengthy cycles of communication with the regulatory agency.
Join Pilgrim Software and Virtify to Learn:
- How to take complete control of the submission document lifecycle and manage complex changes
- How to streamline submission planning, preparation and tracking
- What makes a good submission document
- Why QC and Validating your submission is critical to successful delivery
- The benefits of using an automated, integrated document management and eCTD system
A demo of these concepts is included as part of the webinar.
About Virtify
Virtify is a global company, with headquarters in Cambridge, MA and other international locations in India, Philippines and Bulgaria. Virtify offers cutting edge web-based products and global service delivery capabilities to develop and implement innovative software and services targeting the clinical and regulatory submissions space in the Life Sciences industry. Virtify's clients include several pharmaceutical, and biotechnology companies, and its projects have spanned the R&D lifecycle, from discovery through commercialization. For additional information about Virtify, please visit http://www.virtify.com/