'Well written' eCTD Gateway ANDA filings most efficient
Regulatory approval time lines should be a key focus for all Generic companies, even more important than development time lines. Companies must understand a poorly written application could potentially cost them 12-18 months of time on the market.
Average ANDA approval times are approaching 34 months, most blame the FDA. But is this the case? We don't think so.
The FDA receives applications from a vast array of companies, many from overseas. Custopharm has reviewed documents from over 35 companies, many of the applications we see are 'data dumps' to the FDA. Too much information is submitted to the FDA reviewers which clogs up the system and wastes the reviewers time. Another critical issue is how the ANDA is written, every company has a different style of formatting the application, this also adds time to the review. Language barriers can create confusion to the reviewer, this adds additional questions to the sponsor of the application. Last but not least, many applications are not complete which creates additional cycles of review adding to the work load of the FDA reviewer.
Custopharm can assist with review of the development to assure the ANDA is complete, we can then write a 'well written' application with the FDA reviewer in mind, we also assist with deficiency responses. Custopharm has filed over 100 eCTD ANDA's and over 500 ESG filings, we filed the 1st eCTD ANDA in March 2004. We are good at what we do and are fair to our customers.