Certara Synchrogenix strategically assigned dedicated points of contact and publishers for the project utilizing our global offices, including team members in APAC at our Makati City, PHL office. This greatly facilitated real-time communications and enabled a “follow the sun” publishing model to support accelerated deadlines. Certara Synchrogenix’s Cloud-based infrastructure in its software allowed for multiple, simultaneous users to perform publishing and allowed the team to seamlessly pick up work where others left off. Our VALIDATE software allowed us to identify potential publishing errors early on and remediate them as part of the normal publishing process, which created efficiency and avoided rework up against deadline. Our delta publishing feature meant changes were available almost immediately for the Client’s review and approval, which made any last-minute changes needed easy. Finally, WebReview provided a simple, efficient way for the Client to review the submission, even though they had limited previous experience with electronic Common Technical Document format. The ANDA was submitted on schedule, thanks to the efficient process in working with Certara Synchrogenix, and successfully filed by the Food and Drug Administration for review.

Certara Synchrogenix’s Cloud-based infrastructure in its software allowed for multiple, simultaneous users to perform publishing and allowed the team to seamlessly pick up work where others left off.

Certara Synchrogenix’s team of Regulatory Operations specialists don’t take “no” for an answer. Strategic, global resourcing and technology designed with efficiency in mind make the impossible project with the impossible timeline achievable.

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