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CDMO Services
Regulatory Consulting
A cell processing workstation at Made Scientific

Regulatory Consulting for Cell Therapies

Regulatory strategy built around your cell therapy.

About

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. You keep ownership of your filings and your program.

Services

  • Regulatory assessment and gap analysis

  • Agency meetings, from request to follow-up

  • IND, BLA, and CMC submissions

  • CMC strategy

  • Global regulatory strategy

Our Capabilities

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

Regulatory Assessment

Where your program stands.

  • Development pathway and target product profile

  • Expedited program evaluation

  • Risk-based development planning

  • Regulatory intelligence

Agency Meetings

You go in prepared, communicate clearly, and act on the feedback.

  • INTERACT, Pre-IND, End of Phase 1 and 2

  • EMA Scientific Advice and PRIME

  • Briefing books and rehearsal

  • Post-meeting analysis

IND Preparation

Support for a first filing and beyond.

  • Authoring and compilation support for Modules 2 and 3

  • eCTD submission preparation

  • Amendments and IND maintenance

BLA Preparation

Support through approval and after.

  • Submission strategy

  • Module 2 Quality Overall Summary

  • Module 3 CMC documentation

  • Annual reports and periodic updates

CMC Strategy

CMC work built for living cell products.

  • Phase-appropriate CMC development planning

  • Critical quality attributes

  • Comparability strategies

  • Process validation planning

Global Strategy

Building for more than one market from the start avoids repeat work later.

  • FDA and EMA

  • PMDA, Health Canada, and MHRA

  • Common Technical Document preparation

Support at the moments that matter

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.

Regulatory education, roadmaps tied to financing milestones, academic-to-industry translation, right-sized quality systems, regulatory operations setup, and due diligence support for fundraising, partnerships, and licensing.

See the live page
A Made Scientific scientist in a process development lab

You follow one development strategy across regions and see where requirements differ, with coordinated development strategy, region-specific gap analysis, and ICH guideline alignment.

See the live page
A Made Scientific scientist in a lab

Why Made Scientific for Regulatory

Starts from how it’s made

Because we also develop, manufacture, and test cell therapies, our advice starts from how yours is made.

Agency experience at every step

From request letters and briefing books through attendance and next steps.

Built for living products

Donor eligibility, potency assay development, and cellular characterization.

Your program stays yours

You keep ownership of your regulatory filings and your program.

Regulatory Insights

Technical perspectives from Made Scientific.

Translating Innovation

Made Scientific's eBook guide to cell therapy manufacturing.

Read Article

Structuring your quality by design framework

A Made Scientific article on building quality by design into cell therapy development.

Read Article

Strategies for a successful tech transfer

A Made Scientific article on moving a cell therapy process between teams and sites.

Read Article

Made is easy to work with. We’ve got your back.

We work as an extension of your team. Cell therapy development is rarely linear, so our engagement models are designed to flex with your program as timelines shift and data evolves.

Traditional & Dedicated Service

All Clients

We provide end-to-end solutions with platform processes or purpose-built technology transfer, plus dedicated capacity models to secure your supply chain.

Hybrid Client-In-Plant Operations

Mid-to-Late Stage Clients

We get you started, then step back. GMP-ready labs, cleanrooms, and equipment are available in shared or dedicated settings, supported by specialized experts.

Custom Build-outs & Partnerships

Late-Stage and Commercial Clients

We collaborate on custom lab, cleanroom, warehousing, and cold-chain solutions tailored to your workflow and spatial needs in our expansion areas.

Scientist loading a sample into an analytical instrument
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.

Example page for review. Not published by Made Scientific.