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| iRegulatory is a full-service European pharmaceutical regulatory affairs consultancy. Historically, we have been recognised for our expertise and track-record in eCTD and other electronic submissions, but we also have a rapidly emerging reputation for high quality regulatory affairs consultancy. Our regulatory consultants have submitted many dossiers in paper, eCTD and
other electronic formats through the Centralised (CP), Decentralised (DP)
and Mutual Recognition Procedures (MRP), as well as Responses to Questions,
amendments/variations and Clinical Trial Applications (CTAs). These submissions
have covered many indications and include novel, generic, bio-similar and
veterinary products.
2009-12-31 00:00:00 GMT+00:00Countdown to the deadline for EU national authorities to accept eCTD without paper copies, see below for further information.
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