Preparing to Submit an eCTD?
Legislative action by regulatory agencies has incentivized, and in some cases, mandated electronic submission of healthcare products. Advances in technology are also convincing organizations to switch from paper to eCTD format. Whatever the reason, many companies are making their first foray into electronic submissions, or considering outsourcing to support in-house resources.
Here are a few authentic scenarios that we’ve developed recommendations for in recent months. If any sound similar to a situation you’re currently experiencing, you should talk to us about eCTD readiness.
Company A: An emerging biotech preparing to submit an IND application. Company A has limited in-house regulatory support, and almost zero hands-on experience with eCTD submissions.
Company B: A generic drug company preparing ANDA submissions. Company B recently committed to filing in eCTD format to qualify for the expedited GDUFA timeline. However the FDA’s repeated warnings about ANDA submission quality caused this organization to question its strategy.
Company C: A pharmaceutical company with in-house experience submitting electronically is concerned about mounting infrastructure costs and connecting a network of regulatory professionals working remotely.
Company D: A large life science company that uses a mainstream eCTD publishing solution is readying for a significant NDA submission, and has concerns about meeting the latest regulatory criteria instituted by regional authorities around the world. Company D has also experienced diminishing levels of customer service and support, and is worried that this lack of attention could have serious consequences during the submission process.