Managing the delivery of a large technical document at short notice to an accelerated timeline hero image

Case Study

Managing the delivery of a large technical document at short notice to an accelerated timeline

Regulatory Writing

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Challenge

To deliver a large and complex specialised NDA 2.6.5 submission module at short notice to help a client partner to meet submission timelines
Extracting complex nonclinical pharmacokinetics (PK) and bioanalytical data from approximately 70 technical reports
Completing approximately 200 pages of specialised tabulated technical data in a QC-ready format

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Solution

Effective management by a single point of contact SME at Bioscript, providing training sessions and overseeing the work of the author team on an ad-hoc basis
Effective briefing and status meetings allowed us to get buy-in from key stakeholders ensuring alignment on objectives and timelines
Robust tracking procedures and persistent follow up ensured that the delivery stayed on track
High-quality writing required minimal rounds of review

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Results

Project delivered successfully with positive feedback from client with regard to execution and delivery
Internal teams increased knowledge of a specialised area of science (PK)
Client QC department was extremely happy with the approach – every data value in almost 200 pages of tables were labelled up with source locations to aid the client's QC

Projects in Focus

Regulatory Writing

Modules 2.7.1 to 2.7.4, 2.5, 2.7.5, 2.7.6, 5.2 for BLA MAA Submission thumbnail image

Regulatory Writing

Helping the client to deliver 6 CSRs for one clinical programme simultaneously to aggressive timelines thumbnail image