Case Study

Complex package delivered, to meet accelerated timelines for BLA/MAA submission

Regulatory Writing

Working collaboratively with a cross-functional team, including stakeholders across multiple companies, to meet an accelerated submission timeline for an acquired product

To deliver a complex submission package to help a new client partner to meet tight submission timelines for a priority product
Navigating the complicated dynamics of stakeholders across multiple companies associated with an acquired product
Collaborating with and advising a new client team who did not have previous experience of this type of submission

Effective management by a main point of contact at Bioscript who jointly served as submission lead along with the client lead
Regular briefing and status meetings to allow ongoing flexibility and agile responses to a changing situation
Proactive escalation of issues or potential issues to align on issue resolution
Additional resource provided at short notice, when necessary
Strong relationships built with SMEs and other stakeholders to ensure appropriate document content
Dedicated PM support for admin tasks to allow writers to focus on producing quality documents

Project delivered successfully with positive feedback from client regarding flexibility and delivery under extremely challenging conditions
Repeat work - the client requested Bioscript support for the 4-month safety update
Bioscript is considered a trusted and reliable partner