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RegCORE™ Blueprint Service

Are You 6-12 Months From Your First Clinical Trial, But Not Sure Your Regulatory Strategy Will Hold Up?

Get Your IND/IMPD Roadmap, CMC Gaps, and Regulatory Timeline, Validated by 18 Years of Big Pharma Experience. In Just 30-45 Days. The Reg CORE™ Blueprint gives you a comprehensive regulatory readiness assessment and actionable roadmap so you can move confidently into Phase I without costly delays or submission rejections.

  • 18+ years pharmaceutical industry experience

  • Former regulatory lead at Novartis, Lonza, Sanofi

  • Author of 'The Biologic Blueprint'

  • Specialized in post-seed/Series A biotech companies

RegCORE™ Blueprint

From 15,000€*

  • Complete 4-pillar regulatory assessment

  • 30-45 day delivery

  • Executive presentation + 90 days email support

Are You 6-12 Months From IND Submission But Not Sure You're Ready?

Before you commit another €100K to scale-up or finalize your IND package, find out where you stand. This quick 5-question assessment reveals your regulatory readiness score and identifies your biggest risks, in less than 60 seconds.

Before You Invest €15,000, Invest 30 Minutes

Book a free regulatory readiness call with Jeremy Jakob to see if the RegCORE™ Blueprint is right for your situation. No sales pitch. Just an honest assessment of where you stand.

What Happens on This Call:​

📋 Minutes 0-10: Your Current SituationYou share your timeline, funding stage, and top regulatory concerns.

🔍 Minutes 10-20: Rapid Risk AssessmentWe identify immediate red flags and your 3 highest-priority regulatory risks.

✅ Minutes 20-25: Honest Go/No-Go RecommendationWe tell you if the Blueprint makes sense—or if you need something else entirely.

💬 Minutes 25-30: Your QuestionsOpen Q&A. No topic off-limits

*Base price €15,000.

Complex programs (multi-region submissions, fast track, advanced therapy products) may require custom pricing. Discuss on discovery call.

The €500,000 Question Most Biotech CEOs Can't Answer

Is our regulatory strategy actually going to work when we submit our IND/IMPD?   

You've raised your seed or Series A round. Your science is solid. Your team is motivated. But there's a critical question keeping you up at night:

The Stakes

€50-100K+ monthly burn rate lost per month of delay
Lost competitive advantage in your indication
Increased risk of running out of runway before clinical data
Damage to investor confidenceage

Common Scenarios

  • The Optimistic Surprise — CMC gaps add 9–12 months to your timeline.

  • The Regulatory Rejection  — Poor pre-IND structure leads to major agency objections.

  • The Expensive Pivot — Scale-up investment misaligned with TPP and regulatory needs.

Get Complete Regulatory Clarity Before You Spend Another Euro on Development

The RegCORE™ Blueprint is a comprehensive 30-45 day assessment that evaluates your regulatory readiness across four critical pillars and delivers a detailed roadmap for successful IND/IMPD submission

PILLAR 1: TPP Regulatory Optimization

Alignment Score: 0-100

We evaluate whether your Target Product Profile is structured to meet regulatory requirements:

  • Primary endpoint regulatory acceptability

  • Secondary endpoint strategic value

  • Population selection rationale

  • Dosing strategy regulatory alignment

  • Comparator selection & justification

PILLAR 3:Pre-IND/Scientific Advice Preparation

Strategy Score: 0-100

We develop your regulatory interaction strategy:

  • Question formulation & prioritization

  • Briefing document structure

  • Agency engagement timing

  • Risk mitigation through early dialogue

PILLAR 2: IND/IMPD Pathway Blueprint

Readiness Score: 0-100

We map your complete submission pathway:

  • Module 1: Administrative readiness

  • Module 2: Summary documentation strategy

  • Module 3: Quality (CMC) package assessment

  • Module 4: Nonclinical readiness evaluation

  • Module 5: Clinical protocol optimization

PILLAR 4:CMC Gap Analysis & GMP Readiness

Compliance Score: 0-100

We identify all CMC gaps and GMP requirements

  • Manufacturing process characterization

  • Analytical method validation status

  • Stability program adequacy

  • GMP compliance readiness

​

 

We've seen these issues cause 4-12 month delays and €150K-400K in rework costs.

How many apply to your program?

CMC & Manufacturing (Pillar 4):

 ! Manufacturing process not sufficiently characterized for biologics

 ! Analytical methods lack appropriate validation for Phase I

 ! Stability protocol missing forced degradation studies

 ! No comparability strategy defined for scale-up changes

Regulatory Strategy (Pillars 1-3):

 ! TPP endpoints not aligned with regulatory precedents in your indication

 !  Pre-IND/Scientific Advice timing not optimized for your timeline

 !  Module 2 summaries (Quality Overall Summary) drafted without CMC expertise

 !  Nonclinical package gaps not identified until pre-IND meeting

GMP & Compliance:

 !  CDMO quality agreements missing critical Phase I requirements

 !  Batch records not audit-ready for regulatory inspection

 !  No deviation management system in place pre-FIH

 !  Reference standards and impurity profiles inadequately qualified

 

See 3 or more red flags? Your program likely has critical gaps that need immediate attention.

 The 12 Critical Gaps That Delay IND Submissions

Your Regulatory Roadmap in 4 Simple Steps

STEP 1: Discovery & Documentation Review (Week 1)

Kick-off, document review, CMC status assessment, immediate red flags.

Deliverable: Initial assessment summary with priority areas

STEP 2: Deep Dive Analysis (Weeks 2-3)

TPP alignment, module-by-module readiness, CMC gaps with risk scoring

Deliverable: Comprehensive analysis across all four pillars

STEP 3: Blueprint Development (Week 4)

Custom roadmap, timeline, budget estimates, corrective actions.

Deliverable: Complete Reg CORE™ Blueprint Report (40-50 pages)

STEP 4: Strategic Presentation (Week 5-6)

Executive presentation, Q&A, 90 days support.

Deliverable: Executive summary presentation + 90 days support

Your Complete Regulatory Blueprint Package

Core Deliverable

 Comprehensive Reg CORE™ Blueprint Report (40-50 pages) including an executive summary with overall readiness score, critical findings, timeline and budget estimates, and go/no-go recommendation.

Bonus Materials

  • Executive presentation slides

  • Gap tracking spreadsheet

  • Regulatory document checklist

  • 90 days email support

See What You'll Get: Download a Real Blueprint Example

Here is a real Blueprint example  (a 6-page excerpt from an actual client deliverable). See our analysis methodology, scoring system, gap prioritization framework, and actionable recommendations—all critical information have been anonymized to protect client confidentiality.

Download an example of a complete RegCORE™ Blueprint to see exactly how we structure our analysis, scoring, and recommendations.

€15,000 Investment, €100K-500K+ Savings

RegCORE™ Blueprint

From 15,000*

  • 30-45 day delivery

  • 90 days support

  • No Gaps Left Behind

  • Payment terms: 50% deposit, 50% on delivery

*Base price €15,000.

Complex programs (multi-region submissions, fast track, advanced therapy products) may require custom pricing. Discuss on discovery call.

ROI Breakdown

  • Avoid manufacturing mistakes: €100-300K

  • Eliminate timeline delays: €200-600K potential savings

  • Prevent submission rejections: €150-400K

  • Total potential value: €500K - €1.4M+

"No Gaps Left Behind" Guarantee

If a gap identified in our RegCORE™ Blueprint causes a delay or rejection during your IND/IMPD submission, we will:
✓ Work with you at no charge to resolve the issue
✓ Provide additional regulatory support until clearance

 

Why we can offer this:

In our regulatory assessments across biologics, ADCs, and monoclonal antibodies, we've never had a client face submission delays due to gaps we identified and they addressed.

We stand behind our work—because we know the Blueprint works.

Built on 20 Years of Big Pharma Regulatory

Jeremy Jakob | Founder & Principal Consultant — 18+ years in industry; former regulatory lead at Novartis, Lonza, Sanofi. Author of 'The Biologic Blueprint'. Supported 50+ regulatory submissions across EU and US

Case Study Teaser

Series A cell therapy: Identified 8 critical gaps, saved €250K and 4 months by fixing issues before scale-up.

Testimonials

  • t's been a pleasure working with you. Our company is very satisfied with the work conducted..." — Peter L

FAQ

Q: How is this different from hiring a regulatory consultant?

Reg CORE™ provides quantified scores, a prioritized gap list, timeline and cost estimates,  not just advice. Our base price is €15,000, its content is structured & actionable. 

Complex programs (multi-region submissions, fast track, advanced therapy products) may require custom pricing. Discuss on discovery call.

Q: What if we already have regulatory advisors?

The Blueprint complements existing advisors as an independent regulatory audit and gap prioritisation tool.

Q: How much time does this require from our team?

Roughly 8-10 hours total (kick-off, document queries, final presentation)

Q: Do you work with both IND and IMPD?

Yes !  The framework applies to both FDA IND and EMA IMPD paths, with jurisdiction-specific recommendations

Q: Is the RegCORE™ Blueprint Right For You?

This service is PERFECT for:

✓ Biotech CEOs/CSOs preparing IND/IMPD in next 6-18 months
✓ Series A companies with €2M+ raised, €50K+/month burn rate
✓ Teams making major manufacturing or regulatory commitments (€100K+)
✓ Companies who need independent validation before board updates or investor milestones

This service is NOT a fit for:

✗ Pre-seed companies without a defined lead candidate
✗ Programs >24 months from FIH (too early for detailed assessment)
✗ Companies with <€1M runway remaining (other priorities first)
✗ Teams just looking for "validation" without intention to act on findings

​

Not sure if you qualify? Book a free 30-minute discovery call and we'll tell you honestly.

Stop Gambling With Your Regulatory Strategy

You're 6-12 months from spending hundreds of thousands of euros. Your investors are counting on you. Starting from €15,000, get complete clarity and a validated roadmap.

Request a Quote →

Current Availability:

We limit Blueprint engagements to maintain quality and provide personalized attention to each client.

Q1 2025 Status:

  • January: 2 slots filled, 2 remaining

  • February: 3 slots available

  • March: 4 slots available

Next available kick-off date: January 20, 2025

Slots are filled on a first-come, first-served basis. Reserve yours now to secure your preferred timeline.

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