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Regulatory Consulting for Cell Therapies

Regulatory Strategy Built Around Your Cell Therapy

Made Scientific’s regulatory team works with cell therapy developers on agency meetings and submissions, from early nonclinical studies through commercial approval worldwide. Because we also develop, manufacture, and test cell therapies, our regulatory advice starts from how yours is made.

Gowned operators at a cell processing workstation in a GMP cleanroom

Regulatory Assessment and Gap Analysis

Development pathway, target product profile, manufacturing hurdles, and how your current program measures up

Expedited Program Evaluation

Eligibility for RMAT, Breakthrough Therapy, Fast Track, Orphan Drug, and EMA PRIME

Risk-Based Development Planning

Phase-appropriate strategies that weigh requirements against resources

Regulatory Intelligence

Ongoing monitoring of cell therapy guidance and what it means for your program

Agency Meetings, From Request to Follow-Up

Agency meetings shape a program’s direction. You go in prepared, communicate clearly, and act on the feedback, with our team at every step.


Meeting Types

  • INTERACT
  • Pre-IND
  • End of Phase 1 and End of Phase 2
  • Type B and Type C
  • EMA Scientific Advice and PRIME

What We Handle

  • Meeting request letters
  • Briefing book preparation and review
  • Question and response strategy
  • Presentation development and rehearsal
  • Attendance and representation
  • Post-meeting analysis and next steps
Two gowned operators working at a biosafety cabinet in a cell therapy cleanroom

IND, BLA, and CMC Submissions

From a first IND to a BLA, we prepare the CMC content reviewers look at most closely, along with the rest of your submission.

IND Preparation and Submission

  • Authoring and compilation support for Modules 2 and 3
  • Preclinical data presentation
  • Clinical protocol review
  • eCTD submission preparation
  • Amendments and IND maintenance

BLA Preparation

  • Submission strategy
  • Module 2 Quality Overall Summary
  • Module 3 CMC documentation
  • Publishing and submission
  • Responses to information requests

After Approval

  • Annual reports and periodic updates
  • Post-marketing commitment planning

CMC Strategy

CMC work built for living cell products, from early planning through Module 3 documentation.

  • CMC Development Planning

    Phase-appropriate CMC approaches that evolve with clinical development
  • Critical Quality Attributes

    Definition and justification for complex cellular products
  • Comparability Strategies

    Approaches for showing comparability after manufacturing changes
  • Analytical Method Strategy

    Qualification and validation strategy aligned with product progression
  • Process Validation Planning

    Process validation strategy for cell therapy manufacturing
  • Cell Therapy-Specific Considerations

    Donor eligibility, potency assay development, cellular characterization, and ancillary material qualification

Support for First-Time Filers

Taking a cell therapy to the clinic for the first time is a lot to manage. You get a defined path from discovery to IND, and our team fills the gaps in yours.

Regulatory Education

Workshops on cell therapy frameworks and requirements

Regulatory Roadmaps

Regulatory and manufacturing timelines tied to financing milestones

Academic-to-Industry Translation

Moving academic processes into compliant manufacturing

Right-Sized Quality Systems

Matched to your stage of development

Regulatory Operations Setup

Document management and submission readiness

Due Diligence

Support for fundraising, partnerships, and licensing

Global Regulatory Strategy

Building for more than one market from the start avoids repeat work later. You follow one development strategy across regions and see where requirements differ.

Multi-Region Strategy Development

  • FDA (US) regulatory strategy and submissions
  • EMA (EU) requirements and processes
  • PMDA (Japan) consultation and applications
  • Health Canada regulatory support
  • MHRA (UK) requirements
  • Emerging market regulatory planning

Global Harmonization Approach

  • Coordinated development strategy across regions
  • Region-specific requirements and gap analysis
  • Common Technical Document (CTD) preparation
  • ICH guideline alignment
Scientist in a lab coat and safety glasses with arms crossed in the Made Scientific process development lab
Made Scientific - Interactive Background

From First Filing to Global Expansion

Tell us where your program stands and where you intend to file. We’ll build a regulatory plan around your cell therapy, timeline, and target markets.