Flexibility, Expertise, Results: Bioscript’s Unique Approach to Regulatory Writing
Choosing the right regulatory writing vendor can significantly impact the success of drug development and approvals. What do you look for when shortlisting vendors and how do you choose your partner?
Do you prioritise document or therapeutic area experience? How important is the seniority of support? To what degree does flexibility play a part?
Years of experience show it is often a combination of all these factors, although the balance shifts depending on individual clients and specific needs. Of course, some factors, particularly quality and commitment to timelines, are non-negotiable in regulatory writing.
What sets Bioscript Regulatory Writing (BRW) apart?
We do our utmost to meet clients’ needs by addressing your specific requirements. Our Group consists of a large number of writers (the majority of whom are Senior or Principal Writers), as well as a dedicated Quality Control team (many of whom are ex-writers), Project Management team (to support finances and internal admin tasks), and experienced Management team (all ex-writers with more than 15 years working in the industry). But there is more to consider than headcount and experience.
We tick the boxes for all key considerations:
- Writer and document experience: Highly experienced team who can cover the full range of regulatory writing documents
- Project management and soft skills: Writers integrate with client teams and work both independently and with cross-functional teams to keep documents on track and meet deadlines
- Size of team: Big enough to support a range of clients across multiple documents
- Adaptability: Work with a variety of financial models (time + materials, FSP/FTE, fixed fee)
- Proven track record: Client testimonials speak for themselves
- Price: Competitive rates vs comparable vendors
- Flexibility: Ability to respond to changing timelines and short-notice requests and quickly scale resources up and down as required
Creating an environment for success
We have strived to create and maintain a workplace that fosters engagement and motivation. This is great for BRW and clients as our writers are provided with the tools and space to deliver exceptional results. This is how we make it work:
- Thoughtful recruitment – we recruit writers with appropriate experience and qualifications who share the values and culture of our team
- A high proportion of Senior and Principal Regulatory Writers;
- Allows us to support submission documents and other complex strategic documents
- Provide less experienced writers with appropriate training, mentoring and guidance to allow them to develop document experience while assuring quality
- Senior-level support for both writers and clients – BRW’s Regulatory Writing Directors have overall accountability for the delivery of projects, appropriate resource assignment, and financial oversight and are the main point of contact for escalation
- Agile by design;
- Individual writers have flexibility in their schedules and assigned projects so they are well-placed to deal with changes in timeline and scope and often have small pockets of capacity to support other writers, as needed
- Access to a trusted pool of freelancers (equivalent to Principal Regulatory Writers) who can act as lead or support writers during peak times
Conclusion
In the complex world of drug development, the role of a regulatory writing vendor is not only to produce documents but to act as a strategic partner. A well-chosen vendor, like Bioscript Regulatory Writing, brings a wealth of experience, adaptability, and collaboration that can significantly impact your success. Remember, regulatory writing is about more than words on a page; it’s about crafting a compelling and consistent evidence-based narrative to facilitate approval of your drug and ultimately benefit patients.
Write a new script
Don’t leave your regulatory writing to chance. Partner with a vendor who understands the unique challenges of your documents, who can scale with your needs, and who shares your commitment to quality and timelines.
