Which eCTD and electronic publishing services should I use?
The benefits of eCTD are many. As the mandatory format requirement for several regulatory health authorities – including those in Europe, the US, Canada, Switzerland, Australia, GCC, South Africa, Japan, Thailand and Jordan – eCTDs offer the efficiency, formatting and quality that should always come as standard when bringing a human, medical device or veterinary medicinal product to market. […]
Tips for efficiently preparing eCTD documents
The FDA is just one health authority that has made the submission of ANDAs, NDAs, BLAs, DMFs and Commercial INDs in eCTD format mandatory. With paper and non-eCTD submissions no longer accepted across many application types, getting to grips with the efficient preparation of eCTD documents is a must. To help you on your way […]
