Case Study 3: eCTD Conversion and Submission

The Client...

a global pharmaceutical company that had recently completed a US eCTD filing
was looking to prepare their first eCTD submission in Europe for a novel formulation in a new indication
needed a medical writing and project management resource with in depth knowledge of European CTD requirements to integrate with project teams on both sides of the Atlantic

...so what we did was...

develop and manage the project timelines and milestones from the medical writing perspective
write, edit and QC the Clinical modules of the CTD, and check the Quality and Nonclinical modules for compliance and consistency
liaise with all team members and key internal reviewers to facilitate the review process and keep the project on track
work with the Client's document management groups to compile and validate the eCTD in accordance with EU guidance

...and the outcome was...

the EU eCTD was submitted on time and approval has been obtained
the Client's US team gained a better understanding of EU requirements for future CTD preparation
global working was improved within the Client
Spectrum has since worked with the Client on several spin-off projects as their medical writing providers of choice

Spectrum Regulatory Solutions, Fraser House, 14 Carfax, Horsham, West Sussex RH12 1DZ regulate@spectrumrs.com. Spectrumrs.com is the trading name of Spectrum Regulatory Solutions Ltd. Spectrum Regulatory Solutions is a limited company registered in England and Wales with company number 5331222. Registered office: St James's House, 8 Overcliffe, Gravesend, Kent DA11 0HJ. VAT registration no: 818283318