Submit a strong IND and start clinical trials with a clear regulatory plan
BioBoston supports IND strategy and submission execution so your package is complete, consistent, and aligned to FDA expectations. We help you reduce rework, anticipate questions, and keep timelines moving from preclinical to first in human.
- Experienced regulatory leads for IND programs
Preclinical, CMC, and clinical alignment in one plan
- eCTD ready submission management support
- Support through FDA questions and follow up
Who this is for
This service is a fit if
- You are preparing for a pre IND meeting or building your IND for submission
- Your preclinical, CMC, and clinical sections need stronger alignment
- You want a clear plan to reduce risk of FDA questions or delays
- Your internal team needs experienced regulatory leadership and execution support
- You want a disciplined story that supports safe dosing and trial design
What you’ll get
- You will receive practical IND deliverables such as:
- An IND roadmap with key milestones, owners, and risk areas
- Pre IND meeting strategy and briefing package support when appropriate
- IND submission preparation support across required sections
- Pharmacology and toxicology package review for completeness and clarity
- CMC support to ensure quality, controls, and manufacturing readiness are well supported
- Regulatory submission management support including eCTD readiness
- Support responding to FDA information requests to keep the review moving
What we do
Our IND Application support can include:
Pre IND meeting preparation, strategy, and briefing materials
IND submission preparation and content coordination
Review and organization of pharmacology and toxicology data
CMC support for Chemistry, Manufacturing, and Controls content
Regulatory submission management and eCTD formatting support
Response planning and support for FDA inquiries and follow up questions
Why BioBoston
IND timelines slip when sections are built in silos and the narrative is not consistent
We help you connect the evidence across nonclinical, CMC, and clinical plans so the submission is easier to review, easier to defend, and easier to update as your program evolves
Strategy and content plan
We define the submission approach, identify gaps, and align on deliverables and responsibilities
Build, submit, and support
We support drafting, assembly, and submission readiness, then help manage FDA questions through review
Discovery call
We confirm your product, indication, development stage, and target timeline
How it works
Frequently Asked Questions
Yes. We can support meeting strategy and briefing materials, then carry that alignment into the submission.
Yes. We can support CMC strategy and documentation coordination aligned to your program stage.
Yes. We help draft and coordinate responses to keep progress moving.