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Expert Regulatory Guidance for Cell Therapy Success
Accelerate your cell therapy program with strategic regulatory support tailored to your product and development stage.
Plan with Precision: Regulatory Strategy Aligned to Your Path
Made Scientific helps cell therapy developers navigate FDA, EMA, and other global regulatory agency expectations and streamline submissions. From early nonclinical development studies through commercial approval, our consultative approach integrates seamlessly with your timeline, ensuring compliance while maximizing the efficiency of your path to market.
Accelerate Approval with Regulatory Strategies Built for Cell Therapies
Navigating regulatory pathways for cell-based products requires specialized knowledge and a proactive approach. Made Scientific's regulatory consulting team delivers tailored guidance from discovery to approval.
We are built to translate scientific innovation into compliant, approvable therapies with optimal regulatory strategies that save time and resources.
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Strategic regulatory guidance tailored specifically for cell therapies
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Comprehensive support for agency interactions (INTERACT, pre-IND, EOP1/2)
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Expert preparation of regulatory submissions (IND, BLA)
- CMC regulatory strategy and documentation (Modules 2 & 3)
- Access to regulatory professionals with cell therapy-specific expertise
- Special focus on supporting early-stage companies with limited prior agency experience
Strategic Regulatory Planning to Guide Your Therapy Forward
Whether you’re pursuing North American, European, or global approvals, our team supplies early guidance and ongoing support to reduce risk, identify opportunities, and accelerate development and manufacturing.
Initial Regulatory Assessment
Development pathway determination, target product profile knowledge, and manufacturing technology hurdles
Global Regulatory Strategy
Coordinated approach across multiple markets (US, EU, Japan, etc.) with prioritization recommendations
Expedited Program Evaluation
Assessment for RMAT, breakthrough therapies, fast track, orphan drug designations, and EMA PRIME eligibility
Risk-Based Development Planning
Phase-appropriate strategies that balance regulatory requirements with resource considerations
Regulatory Gap Analysis
Evaluation of current development programs against regulatory requirements with actionable recommendations
Regulatory Intelligence
Ongoing monitoring of evolving cell therapy regulations and their impact on your development program
Maximize Every Agency Interaction with Expert Guidance
Regulatory meetings are vital to progressing your cell therapy. Made Scientific provides end-to-end support for agency engagements, helping you prepare strategically, communicate clearly, and align early to keep your program on track.
Meeting Preparation & Strategy
- INTERACT meeting preparation and representation
- Pre-IND meeting strategy and support
- End of Phase 1/2 meeting preparation
- Type B and Type C meeting management
- EMA Scientific Advice and PRIME meetings
Comprehensive Meeting Support
- Meeting request letter drafting
- Briefing book preparation and review
- Question formulation and response strategy
- Presentation development and rehearsal
- Meeting attendance and representation
- Post-meeting analysis and follow-up strategy
Complete Cell Therapy Regulatory Submission Services
From early-phase INDs to late-stage BLAs, Made Scientific provides comprehensive submission support tailored to cell therapy products. Our regulatory experts ensure every stage, from CMC to commercial, is complete, compliant, and strategically aligned.
IND Preparation and Submission
- Guidance and support on IND authoring and compilation for Modules 2 and 3
- CMC section development and review of Modules 2 and 3
- Preclinical data evaluation and presentation
- Clinical protocol review and refinement
- Electronic submission preparation (eCTD format)
- IND maintenance and amendment support
BLA Preparation
- Comprehensive BLA strategy development
- Module 2 Quality Overall Summary preparation
- Module 3 CMC documentation
- Regulatory publishing and submission
- Response to regulatory questions and information requests
Other Regulatory Documents
- Annual reports and periodic updates
- Post-marketing commitment planning
CMC Strategies that Anticipate Regulatory Hurdles
Our team provides CMC regulatory support designed for the complexities of cell therapy products. From early-phase planning to detailed submission documentation, we help you build strategies for compliance, scalability, and approval.
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CMC Development Planning
Phase-appropriate CMC strategies that evolve with clinical development
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Critical Quality Attribute Definition
Identification and justification of critical quality attributes for complex cellular products
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Comparability Strategies
Approaches for demonstrating product comparability following manufacturing changes
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Analytical Method Qualification/Validation Strategy
Regulatory-compliant approach to method development aligned with product progression
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Process Validation Planning
Comprehensive process validation strategies for cell therapy manufacturing
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Cell Therapy-Specific Considerations
Expert guidance on donor eligibility, potency assay development, cellular characterization, and ancillary material qualification
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CMC Regulatory Documentation
Preparation of high-quality CMC sections for regulatory submissions (Module 3, Quality Overall Summary)
Regulatory Support Designed for First-Time Filers
Bringing a cell therapy to the clinic for the first time can be overwhelming, but you don’t have to navigate it alone. Made Scientific simplifies regulatory complexity, fills internal gaps, and builds a clear path from discovery to IND and beyond.
Regulatory Education
Customized workshops on cell therapy regulatory frameworks and requirements
Agency Communication Strategy
Guidance on effective communication approaches with regulatory authorities
Regulatory Roadmapping
Development of integrated regulatory and manufacturing timelines aligned with financing milestones
Academic-to-Industry Translation
Support for transitioning academic processes to regulatory-compliant manufacturing
Right-Sized Quality Systems
Implementation of appropriate quality systems that match company development stage
Regulatory Infrastructure Development
Establishing document management systems and regulatory operations capabilities
Regulatory Due Dilligence
Support for fundraising, partnerships, and licensing activities
Global Regulatory Strategy Without Complexity
Expanding into global markets demands coordination across diverse regulatory frameworks. Made Scientific provides comprehensive global regulatory support that reduces redundancies, aligns with agency guidelines, and maximizes the return on every investment.
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) post-Brexit considerations
- Emerging market regulatory planning
Global Harmonization Approach
- Coordinated development strategy across multiple regions
- Identification of region-specific requirements
- Gap analysis between regional requirements
- Common Technical Document (CTD) preparation
- International Conference on Harmonisation (ICH) guideline implementation
From First Filing to Global Expansion
Connect with our regulatory team to develop a strategy tailored to your product, timeline, and target markets. Whether you’re preparing for your first IND or scaling globally, we’ll help you navigate every step with confidence and clarity.