MUNICH, GERMANY and OTTOBRUNN, GERMANY--(Marketwired - Apr 29, 2013) - EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, today announced that eCTDmanager, its submission and lifecycle management solution, now supports the assembly and publishing of Premarket approvals (PMA), 510(k) premarket notifications and Investigational Device Exemptions (IDE) in eCopy format as required by the FDA's Center for Devices and Radiological Health (CDRH).
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Food and Drug Administration Safety and Innovation Act (FDASIA), beginning Jan. 1, 2013, the FDA will only place a pre-market submission under review if it has received an eCopy. Applications submitted without an eCopy, and eCopy submissions that do not meet the standards provided in the agency's specifications, will be placed on hold until a valid eCopy is submitted and verified to meet these standards, unless a waiver or exemption has been granted.
An electronic copy is defined as an exact duplicate of the paper submission, created and submitted on a CD, DVD, or a flash drive. CDRH requires both eCopy and paper formats of the submission.
Medical Device companies filing regulatory applications with the FDA are in need of a solution that makes their submissions comply with the new mandates. EXTEDO already has a solution on the market that supports the creation of eCopies: eCTDmanager is an off-the-shelf electronic submission management solution that fulfills all requirements for eCopy submissions. eCopies, both electronic and paper submissions can be generated from a single assembly. Furthermore, eCTDmanager allows creating custom templates for generating eCopy submissions.
The validation criteria for eCopy submissions will be included in the solution in a release later this year.
EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management. The complete EXTEDOsuite is unique in all that it covers within eRegulatory Affairs: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Labeling Management and Document Management.
EXTEDO provides configurable off-the-shelf products, as well as customized and integrated solutions. EXTEDO also provides EURS is Yours, the validation, review and approval system for the EMA and more than 25 Regulatory Authorities worldwide.
Today EXTEDO serves more than 700 customers in 57 countries ranging from small companies with less than 25 employees to large multi-national organizations. EXTEDO operates in the following markets for human, veterinary and crop protection: Life sciences, including pharmaceutical, biotech and biopharma, generics, homeopathics and medical devices, healthcare and public sector.
For more information visit www.extedo.com.
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