Regulatory Writing
Flexible solutions delivered with integrity

Regulatory writing

Bioscript provides exceptional regulatory writing services, catering to the diverse needs of the biopharmaceutical industry. Our commitment to excellence is reflected in our flexible approach, consultative methodology, extensive experience, authentic guidance and consistent focus on quality.

At Bioscript Group, our approach to regulatory writing is founded on flexibility and a commitment to exceed expectations. Our highly experienced regulatory writers and submission leads will integrate seamlessly into your team, providing innovation and expertise to produce high-quality, concise content that adheres to regulatory requirements. We are dedicated to creating documents that are clear, compelling and ultimately lead to successful submissions.

A TRUE PARTNERSHIP

We partner with you, your programme and your team, driven by a shared vision for regulatory success. Your next submission could be the start of a lasting partnership.

We have expertise across the full spectrum of clinical documentation:

IND/CTA

  • Meeting requests and briefing packages
  • Regulatory responses
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Clinical Development & Post-Marketing

  • Clinical study protocols and amendments
  • Informed Consent Forms (ICF) & amendments
  • Investigator's Brochures (IB) & updates
  • Clinical Study Reports (CSR) including modular and non-interventional
  • Patient narratives
  • Meeting requests and briefing packages
  • Pediatric Investigation Plans (PIP)/Ped Plans (PSP)
  • Post-authorisation Safety Study (PASS)
  • Aggregated safety reporting
  • Risk Management Plans (RMP)

Marketing Applications (NDA/MAA/BLA)

  • Module 2.5
  • Modules 2.7.1-2.7.6/5.2
  • Priority review requests
  • FDA assessment aids
  • Biomarker reports
  • Diversity plans
  • Regulatory responses
  • Safety updates

Other

  • Post marketing safety reports
  • Lay language documents
  • Transparency and disclosure
  • Medical device documentation (e.g., CERs)
  • Promising innovative Medicine (PIM) designation

WHY CHOOSE BIOSCRIPT GROUP FOR YOUR REGULATORY WRITING NEEDS?

1

Flexibility

At Bioscript Group, we understand the dynamic nature of the regulatory environment. Our team is adept at adapting to changing requirements and timelines, enabling our clients to navigate the complexities of regulatory submissions with ease. Our wealth of experience enables us to anticipate potential challenges and mitigate against them in a collaborative manner, but when the unexpected does happen, we have the agility to respond quickly and effectively.

2

Consultancy

Our consultative approach is central to our success. We work closely with our clients, engaging in open and transparent communication to understand fully their goals and objectives. Our writers can provide strategic insights and suggest innovative solutions, enhancing the overall effectiveness of the regulatory writing process. Through authentic partnership and understanding, we ensure that our clients’ regulatory documents are aligned with their broader business strategy.

3

Innovation

We also offer an advanced agentic AI solution to reduce the time required to produce that critical first draft. Our writers retain full responsibility for quality delivery and their skills, together with the application of technology, bring marked benefits to our clients.

4

Specialising in complex therapeutic areas

We have significant expertise in navigating intricate therapy areas, including rare diseases, oncology, haematology, immunotherapy and other complex disease states. Our specialists bring a deep understanding of the unique challenges and opportunities within these fields, providing the knowledge you need to develop effective strategies tailored to your specific therapeutic focus.

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Thank you for the great job! It felt like this report was writing itself, and this is a strong testimony of how independent, efficient and professional you have been in the background. Thank you very much!!  I never cease to be amazed by this group of medical writers, you guys sincerely rock!
I would like to thank you and your team of writers that you provided for a great job.  Without the Bioscript team it would have been very difficult if not impossible for us to be this successful.  Please congratulate everyone involved on our behalf.
Thank you all very much for your work on this project. We have really appreciated the expertise that your team brought to all aspects of the CSR development process and are looking forwards to continuing to work with the team in the future.
It’s been an absolutely great experience working with Bioscript and looking forward to working together again on more projects!
Thank you so much both for your leadership and great management of this briefing document – it’s not easy to keep up with content shifts in view of the evolving strategy.
I can’t tell you how much I and the team have appreciated your flexibility and understanding with the continuous changes and updates that have come up during the CSP development. You managed the team incredibly well to ensure there was clarifications where needed and more importantly decisions.
Thank you so much for all your hard work! It was a pleasure working with you on this project, you’ve really been flexible with our different challenges and so supportive to me and the team. I hope we will be able to work together in the future.

Integrated capabilities for streamlined strategy and enhanced access

As your consultative partner, Bioscript Group provides truly integrated solutions underpinned by our global expertise in strategic planning, scientific communications, data insights, market access and regulatory writing. Our domain expertise allows us to partner with you, offering clear guidance as you navigate internal departments efficiently, external stakeholders and international markets to achieve your goals.

Let’s tell your scientific story with clarity and impact

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Send a message

Alternatively, you can email us at discover@bioscriptgroup.com or call +44 (0)333 222 4269

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