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Document Management

For regulatory dossiers format truly matters. Doing things right from the beginning is definitively the shortest and most cost efficient way to submission.

As members of the 1K club at Lorenz Life Sciences Group, the IWA Consulting Team offers to handle your eCTD in a validated, dedicated, and protected environment meeting CFR Part 11 specification, allowing for easy review of the eCTD while it is being compiled and facilitating safe long distance cooperation. We use Lorenz’ docuBridge for creating, viewing, validating, and publishing dossiers.

Document Management

At IWA Consulting we have long term and hands on experience in handling eCTDs, and we know what it takes preparing documents and templates that are e-compatible.

We have expertise in establishing workflows and reviewing cycles that run efficiently, and to establish the routines for finalizing and sign off of quality controlled documents.

Our team of experienced specialists also offers on-site or off-site assistance or training for a successful conversion to eCTD.

Whether you are facing dossier preparation, primary submission, or life cycle management, we have the expertise and the experience to advice and assist you before, during, and after.

For more information about document management, please contact RA Operations Team.