Investigational New Drug Application Support
Sponsors seeking to conduct clinical trials in the United States (US) must submit and receive approval of an Investigational New Drug (IND) application.
Boyds provides end-to-end IND application support, helping biotech and pharmaceutical companies prepare and submit high-quality INDs with confidence, while streamlining interaction with the US Food and Drug Administration (FDA) during the IND review period.
What is an IND application?
An IND application is a consolidation of all the information (nonclinical, manufacturing, clinical) that supports an investigational medicinal product’s (IMP) risk/benefit profile, and its future use in humans. The IND is specific to an IMP (or combination of IMPs), and proposes its use in an explicit population and clinical indication. Its approval allows drug developers to ship IMP and run clinical trials within the US under the FDA’s jurisdiction.
Why partner with Boyds?
US regulatory expertise
US regulatory expertise
Integrated development expertise
Integrated development expertise
Strategic and operational support
Strategic and operational support
US Agent and FDA interface
US Agent and FDA interface
Experience across modalities
Experience across modalities
Robust IND project management
Robust IND project management
Our IND application support services
Strategy and planning
- Strategic input into the anticipated contents of each module comprising the IND, tailored to the specific development program
- Mapping and incorporation of prior FDA feedback (e.g. INTERACT, Pre-IND)
- Regulatory pathway and risk mitigation planning
IND authoring
Including but not limited to:
- Nonclinical summaries
- Manufacturing / CMC summaries
- Investigator’s Brochure
- Clinical study protocol
- General Investigational Plan
Submission and publishing
• In-house eCTD publishing
• FDA Electronic Submissions Gateway management
• Submission readiness and QC
FDA interaction
- Support for addressing FDA Requests for Information during the IND review
- Direct liaison with FDA stakeholders during application review
- Ongoing IND lifecycle development support
IND experience across modalities
No two IMP development programs are the same. Whether it’s the IMP class, formulation, route of administration or dosing regimen, or the specific clinical indication and population, an IND is a bespoke collection of documentation that requires appropriate context. Further, scientific innovation often outpaces regulatory guidance, necessitating de novo strategies for cutting edge therapies.
Whether it’s leveraging the most applicable FDA regulation, guidance or predicate reviews, or providing novel regulatory approaches for innovative IMPs, Boyds’ understanding of the need for a unique approach for each IND best ensures a successful review outcome.
- When should you engage IND support?
IND submission is not a standalone milestone – it is the outcome of effective translational planning and regulatory strategy. Engaging IND expertise early helps define a clear regulatory roadmap, align nonclinical, clinical, and manufacturing development, and inform the critical path through FDA engagement.
Boyds’ regulatory affairs professionals are often integrated into development programs well ahead of IND submission, providing continuity, strategic oversight, and early risk identification that supports a smoother FDA review.
As every IMP development program is unique, Boyds tailors its approach, whether supporting first-in-human development, a reformulation or new use of an approved product, or US clinical trial initiation following global development.
Boyds supports IND development at every stage, from early strategy through to FDA submission and review.
Back to Regulatory Affairs
Back to Regulatory Affairs
Looking to file in the UK or Europe?
Specialist support for EMA, MHRA & national submissions
Find out moreReady to progress your IND with confidence?
Whether you’re preparing a first-in-human IND or expanding clinical development into the US, our experts can support you at every stage.
UK: +44 (0)1270 270010
US: +1 800 982 7431
Email: info@boydconsultants.com
Get in touch
If you’d like to talk to a member of our team about a specific project or area of expertise, then please complete this form and we’ll get back to you.