Our client, a mid-sized global biopharmaceutical company, with a volume of some 600 – 800 submissions per annum, required Publishing and Submissions Management support for their eCTD and CSR submissions. They were seeking a vendor able to work collaboratively with their team to support both the creation and updating of work instructions, process guides, and a QC checklist. In addition to the creation, maintenance, publishing, and archiving of their submissions.

Read our latest case study and learn how we have successfully delivered Publishing and Submission Management Services for our client ensuring First-Time-Right submissions. Over a six month period our client has benefited from:

• 300+ successful First-Time-Right submissions
• 100% adherence to submission timelines
• 0% technical rejection from the HA

Please complete the form to download our case study.

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