Regulatory Submissions: overview

A smooth submission is the result of what happens day to day, every day, with the right people, processes and systems all working in harmony. Regulatory submissions still need to be well-written, with positive benefit-risk ratio shown and every point of the proposed labeling defended. At local Eastern European markets it’s essential to have EMA (preferable) or FDA approval on hand by the time of local application. But it’s still takes a lot of effort and time to prepare a local package and wade through all the red tape. That’s where CTX4 can come in and help you save time and effort.

We can prepare a submission package for application to local authorities using your dossier. We will request and collect all required documents, make necessary translations into local language, print out and compile electronic documents and paper folders. On your behalf we will register prepared submission on-line or (if required) apply in person at designated regulatory authorities (RA) office. We can manage all subsequent RA requests, control timeframes and provide you with status updates.

With our extensive experience of regulatory submissions, we have identified bottlenecks and are prepared to mitigate risks before they create costly delays. From our practical experience, timely regulatory approvals at local markets are primarily hampered by haste in preparing submission documents and inevitable mistakes. Mistakes result in RA queries that, however small corrections they may require, postpone final approval. By carefully checking documents and proofreading them, we may spend additional time for preparation but are surely rewarded with faster receipt of approval.

Working in a region with attractive cost-effectiveness, we also offer you an opportunity to manage your global submission projects with better economical results using our service for certain tasks facilitation. Once you break down your project tasks into small chunks of work that need to be done, analyze the optimum way to handle each task. It may be the case that outsourcing some of them to us will become the best solution available.