PPD IND-in-a-box solution

A streamlined IND-in-a-Box solution

from PPD FSP Regulatory Affairs solutions

Your IND should accelerate U.S. clinical entry—not slow it down

For sponsors pursuing U.S. clinical development, the Investigational New Drug (IND) is a critical gateway. It is where regulatory strategy, clinical planning, Chemistry, Manufacturing and Controls (CMC) readiness and nonclinical evidence come together in a way that meets Food and Drug Administration (FDA) expectations.

When those elements are misaligned, the impact is significant: rework, agency questions, delayed submission or clinical hold risk.

PPD™ Functional Service Partnership (FSP) Regulatory Affairs solutions help sponsors move through this milestone with greater clarity, speed and predictability through IND-in-a-Box — a streamlined, submission-ready offering built around defined scope, integrated delivery and set-price confidence.

Reduce the risk of avoidable delay with IND-in-a-Box

Many IND challenges are not caused by writing alone. They happen when clinical, nonclinical, CMC and regulatory inputs are not aligned early enough.

IND-in-a-Box from PPD FSP Regulatory Affairs solutions is designed to reduce that risk by bringing the core IND workstreams together in a structured, FDA-aligned process. Our solution allows sponsors to move toward U.S. clinical entry with a streamlined, FDA-aligned approach designed to reduce rework, improve coordination and support confident clinical progression.

With a set-price model for the core package, sponsors gain greater budget predictability, clearer internal planning, and a faster path to decision-making compared with open-ended or time-and-materials approaches.

Move faster, stay focused and preserve optionality

The IND-in-a-Box core offering includes the essential services needed to prepare a submission-ready IND application, including:

  • IND application support
  • IND start-up and project management
  • U.S. agent services
  • Module 1 authoring and quality review
  • Module 2 clinical authoring and quality review
  • Module 2 nonclinical authoring and quality review
  • Module 3 CMC authoring and quality review
  • Publishing and FDA submission support

This defined package helps sponsors focus on what is required for submission readiness while avoiding unnecessary over-scoping at the start of the engagement.

Flexible IND submission feature set

Add support where it creates value

Not every program needs the same level of strategic support on day one. IND-in-a-Box allows sponsors to begin with a focused core package and add services based on program needs, including:

  • Pre-IND meeting support
  • Briefing book and FDA debrief support
  • Protocol and informed consent form authoring
  • IND maintenance, amendments and development safety update report (DSUR) support
  • Investigator’s brochure authoring
  • Strategic program assessment
  • Target product profile development
  • Clinical development planning

This phased approach enables sponsors to preserve flexibility while maintaining access to deeper regulatory and development expertise when needed.

Our solution is built for U.S. market entry and regulatory capacity

IND-in-a-Box may be an ideal fit for emerging biotech companies, virtual sponsors, small and midsized biopharma organizations, global sponsors entering the U.S. or teams that need additional FDA-specific regulatory writing and submission capacity.

PPD FSP Regulatory Affairs solutions help sponsors answer critical readiness questions:

  • Are your clinical, nonclinical and CMC components aligned for FDA review?
  • Do you have the U.S. agent support required for IND filing?
  • Is your dossier structured for efficient submission?
  • Are you focused on what is essential for clinical entry?
  • Could a phased approach preserve budget while maintaining quality?

PPD FSP Regulatory Affairs solutions combine FDA-aligned regulatory expertise, medical writing, publishing support, U.S. agent services and scalable delivery capabilities across the clinical development lifecycle.

With IND-in-a-Box, sponsors gain:

  • A clear scope for the core IND package
  • Set-price predictability
  • Integrated regulatory, clinical, nonclinical and CMC support
  • Quality-controlled, publishing-ready outputs
  • Optional strategic services when the program requires them
  • A partner positioned to support the path beyond IND submission

IND-in-a-Box gets you to submission with speed, quality and confidence—so you can focus on what matters most.

Ready to make your IND a launch point – not a bottleneck?

Connect with PPD FSP Regulatory Affairs solutions to explore how IND-in-a-Box streamlines U.S. clinical entry with defined scope, set-price predictability and FDA-aligned regulatory support.

Start the conversation and move toward submission readiness today.