RelyAInt for startups
Inspection-ready.
Investor-ready.
From day one.
Your first regulatory inspection or investor due diligence review will expose every gap in your compliance programme. RelyAInt gives your team a structured platform to find those gaps first — before the regulator or investor does.
Situation 01
First inspection approaching
FDA, EMA, or local authority inspection imminent. Limited internal QA expertise. No structured compliance programme. 48 hours to a defensible findings register.
Situation 02
Investor or partner due diligence
Series A, Series B, or strategic partner requesting evidence of compliance maturity. Demonstrate a structured, documented programme — not a spreadsheet and a prayer.
FDA · EMA · MHRA · SAHPRA
From $300 per assessment
No QA consultant needed
48hr findings delivery
The startup compliance challenge
The compliance gaps that derail startups
Most pharma and medtech startups know they have compliance gaps. The problem is finding them in a structured, defensible way — before an inspector or investor finds them first.
No structured QMS from day one
Most startups build their quality management system reactively — documenting what exists rather than designing what's needed. By the time the first inspection arrives, the QMS has gaps that were never identified, let alone closed.
First inspection with no compliance baseline
A first FDA or EMA inspection without a documented compliance baseline is one of the highest-risk events in a startup's regulatory lifecycle. Without a structured GAP assessment completed before the inspection, your team cannot demonstrate control — they can only react.
Investor due diligence exposing compliance immaturity
Series A and Series B investors increasingly include regulatory due diligence in their investment reviews. A startup that cannot produce a structured compliance programme with documented findings and corrective actions signals operational risk — and delays or kills the round.
Limited internal QA expertise
Early-stage startups rarely have a dedicated Head of Quality. Compliance responsibilities fall on founders, CTOs, or part-time consultants — none of whom have the bandwidth to build and maintain a structured compliance programme while also running the business.
Regulatory framework uncertainty
Which FDA regulations apply to your product? Which EMA annexes are relevant? Do you need ISO 13485, ICH Q10, or both? Startups without deep regulatory expertise waste months researching the wrong frameworks — or worse, building compliance programmes against the wrong standards entirely.
RelyAInt closes all five gaps
A structured platform your team can use from day one — no QA consultant required. AI maps your situation against the correct regulatory frameworks, classifies findings, and generates corrective actions. Your team confirms and manages everything within the portal.
Your team can have a structured compliance baseline within 48 hours.
Upload your evidence, run your assessment, review AI-classified findings — inspection-ready and investor-ready documentation delivered to your portal.
How RelyAInt helps
Two situations.
One platform.
Whether you're preparing for your first regulatory inspection or demonstrating compliance maturity to an investor, RelyAInt structures the workflow your team needs to get there.
Situation 01
Your first regulatory inspection is approaching — and you need a defensible compliance baseline fast
The biggest mistake startups make before a first inspection is assuming their existing documentation is sufficient. RelyAInt surfaces what's actually missing — structured, classified, and actionable — before the inspector does.
1
Upload your existing documentation
SOPs, batch records, validation documentation, quality manuals — whatever you have. Your team uploads evidence to the platform.
2
AI maps against your regulatory framework
The platform identifies which controls apply to your situation — FDA, EMA, or local authority — and assesses your current documentation against each one.
3
Your team reviews AI-classified findings
Every gap is classified as Critical, Major, or Minor. Your qualified team confirms the classification — no determination is published without human sign-off.
4
Corrective actions generated and assigned
The platform generates structured corrective actions for Critical and Major findings — assigned to your team with evidence requirements and due dates.
5
Inspection-ready report in 48 hours
A structured GAP register, corrective action log, and executive summary — all inspection-defensible and delivered to your client portal.
Early-stage biotech · USA
Pre-IND FDA inspection readiness — completed in 6 weeks with a one-person QA team
A US-based early-stage biotech with one part-time QA consultant used RelyAInt to build their first structured compliance baseline ahead of an FDA pre-IND meeting. No prior GAP assessment had been completed. The team had 6 weeks.
22
Findings identified — 3 Critical, 9 Major, 10 Minor
48hrs
From evidence upload to structured findings register
6wks
All Critical and Major findings closed before meeting
0
External consultants engaged throughout
What your inspection-ready package includes
Structured GAP register with Critical, Major, Minor classification
Corrective action log with evidence upload trail
Regulatory reference mapping — every finding linked to the specific requirement
Executive summary for leadership and board
Technical inspector report — traceable decision logic throughout
Situation 02
Your investor or partner is requesting evidence of compliance maturity — and you need to demonstrate it fast
Regulatory due diligence is now standard in Series A, Series B, and strategic partnership reviews. A startup that can produce a structured compliance programme with documented findings, corrective actions, and an improving maturity score stands out — and closes faster.
1
Run a compliance maturity assessment
Your team runs a structured GAP assessment against the relevant regulatory framework — producing an overall compliance maturity score alongside the detailed findings register.
2
Generate a due diligence-ready report
The platform produces an executive summary and technical report — structured to demonstrate that your team understands the compliance landscape, knows the gaps, and has a documented remediation plan.
3
Show a traceable corrective action programme
Investors want to see that gaps are being closed — not just identified. The platform's action tracker shows findings, assigned actions, evidence uploaded, and closure status in real time.
4
Demonstrate improving maturity over time
Run repeat assessments as you close findings. Each assessment produces an updated maturity score — demonstrating a continuous improvement trajectory that investors and partners can track.
5
Request expert review for investor confidence
For high-stakes rounds, request a RelyAInt expert to review and validate your compliance programme — adding independent assurance to your due diligence package.
Series A medtech · Europe
ISO 13485 and CE marking compliance maturity demonstrated ahead of Series A close
A European medtech startup approaching Series A close was asked by the lead investor to provide evidence of ISO 13485 compliance maturity and a documented CE marking readiness programme. The founding team had no dedicated QA resource and a 4-week deadline.
4wks
Full due diligence package delivered within investor deadline
68%
Compliance maturity score — documented and improving
18
Findings with structured CAPA programme — all documented
✓
Series A closed — investor satisfied with compliance programme
What your investor due diligence package includes
Overall compliance maturity score with trend over time
Structured GAP register — findings classified by severity
Documented CAPA programme with evidence of closure
Executive summary structured for non-technical audiences
Expert review validation available for high-stakes rounds
Case studies
How startups use RelyAInt
Two anonymised case studies showing how early-stage companies used the platform to prepare for their first inspection and demonstrate compliance maturity to investors — without external consultants.
Early-stage biotech · USA
First FDA inspection readiness achieved in 6 weeks — one part-time QA resource, zero external consultants
A US-based early-stage biotech preparing for a first FDA pre-IND meeting had never completed a structured compliance baseline. One part-time QA consultant, no prior GAP assessment, and 6 weeks to demonstrate regulatory readiness.
48hrs
From evidence upload to structured findings register
22
Total findings identified — 3 Critical, 9 Major, 10 Minor
6wks
All Critical and Major findings closed before meeting
0
External consultants engaged throughout
The challenge
The founding team had been building their product for 18 months with no structured compliance programme. Documentation existed but had never been assessed against FDA requirements. The QA consultant had been engaged part-time for 3 months and had no clear view of where the gaps were or how serious they were. With 6 weeks to the pre-IND meeting, they needed a structured baseline immediately.
Outcome: All 3 Critical and 9 Major findings closed within the 6-week timeline with documented evidence. The pre-IND meeting proceeded as planned. FDA reviewers noted the structured compliance documentation as evidence of a well-governed development programme. The part-time QA consultant now maintains the compliance programme within the platform on an ongoing basis.
Finding breakdown
Critical3 findings — audit trail configuration, electronic records control, and data integrity governance
Major9 findings — SOP gaps, training record currency, change control process, and risk management documentation
Minor10 findings — document version control, review scheduling, and supplier qualification records
Series A medtech · Europe
ISO 13485 compliance maturity documented and presented to lead investor — Series A closed on schedule
A European medtech startup approaching Series A close was asked by the lead investor to provide evidence of ISO 13485 compliance maturity and a documented CE marking readiness programme. No dedicated QA resource. Four-week deadline.
4wks
Full due diligence package delivered within investor deadline
68%
Compliance maturity score — documented and improving
18
Findings with structured CAPA programme — all documented
✓
Series A closed — investor satisfied with compliance programme
The challenge
The founding team had assumed ISO 13485 compliance was a post-funding priority. When the lead investor's due diligence team requested a compliance maturity report, the startup had no structured programme to present — only a collection of SOPs and a partially completed quality manual. With 4 weeks to the investor deadline and no dedicated QA resource, they needed a structured compliance programme documented and presented fast.
Outcome: A full compliance maturity assessment completed within 72 hours of evidence upload. Executive summary and technical findings package delivered to the investor within the 4-week deadline. The documented CAPA programme — showing 18 findings with structured corrective actions and an improving maturity trajectory — satisfied the investor's due diligence requirements. Series A closed on schedule.
Finding breakdown
Critical2 findings — risk management file incompleteness and post-market surveillance gaps
Major8 findings — design control documentation, supplier qualification, and CAPA process gaps
Minor8 findings — document control formatting, training records, and management review scheduling
Platform fit by stage
Built for every startup stage
Whether you're building your first QMS or scaling a compliance programme ahead of a growth round, RelyAInt fits where you are — and grows with you.
Pre-seed · Seed
Building from scratch · No QMS yet
No compliance programme in place. Founders or a part-time QA resource managing regulatory responsibilities alongside everything else. First inspection or investor review is the trigger.
Primary use cases
First compliance baseline — identify what's missing before the inspector does
Regulatory framework identification — which FDA, EMA, or local requirements apply to your product
QMS gap assessment — structured findings with corrective actions to close gaps fast
Seed investor compliance pack — maturity score, findings register, CAPA programme
Typical frameworks
FDA 21 CFR (early-stage IND and NDA requirements)
ISO 13485 (medical device QMS)
ICH Q10 (pharmaceutical quality system)
Local health authority requirements
Recommended plan
Starter — 5 credits/mo
$1,500/mo
Series A
First institutional round · Compliance programme underway
Some compliance infrastructure in place but gaps remain. Investor due diligence and first regulatory inspection are both imminent. Need to demonstrate a structured, improving compliance programme quickly.
Primary use cases
Series A due diligence package — maturity score, findings, documented CAPA programme
First FDA or EMA inspection readiness — structured GAP assessment and corrective action workflow
CE marking and ISO 13485 compliance readiness for European market entry
Expert review escalation for complex findings requiring senior regulatory sign-off
Typical frameworks
FDA 21 CFR Parts 210, 211, 820
EMA Annex 11 and EU GMP
ISO 13485 and MDR 2017/745
ICH Q8, Q9, Q10 quality trilogy
Recommended plan
Growth — 10 credits/mo
$2,500/mo
Series B+
Scaling operations · Multi-market compliance
Established compliance programme but growing complexity. Multiple markets, multiple regulatory frameworks, and a compliance team that needs structured tooling to maintain consistency and speed as the organisation scales.
Primary use cases
Series B due diligence — demonstrating maturing compliance programme with trend data
Multi-market compliance programme — FDA, EMA, MHRA simultaneously
Data integrity programme assessment ahead of commercial manufacturing scale-up
Fixed-price deep-dive GAP assessments for complex pre-NDA or pre-BLA situations
Typical frameworks
FDA 21 CFR — full NDA/BLA compliance requirements
EMA · MHRA · SAHPRA · TGA multi-jurisdiction
ICH Q-Series full suite
GVP pharmacovigilance requirements
Recommended plan
Enterprise — 20 credits/mo
$4,500/mo
Ready to get started
Your team can have a structured compliance baseline within 48 hours.
No external consultants. No blank pages. Upload your evidence, run your assessment, confirm AI-classified findings, and generate an inspection-ready or investor-ready report — all within your client portal.
Self-serve — your team runs the workflow
48hr findings delivery
From $300 per full assessment
Cancel anytime
$300
Per full assessment on Starter plan — vs. $40,000+ for a consultant
48hrs
From evidence upload to inspection or investor-ready report
1,400+
GxP controls — FDA, EMA, ISO 13485, ICH and more
95%
Less cost per assessment vs. traditional consultancy
The cost reality
Startups can't afford $400/hr compliance consultants — and they don't have to.
A single external regulatory consultancy engagement for a first inspection readiness review costs $20,000–$80,000 and takes 4–8 weeks. RelyAInt delivers the same structured output for a fraction of the cost — with your own team in control of the workflow.
$40,000+
Traditional consultancy — single inspection readiness engagement
$1,500/mo
RelyAInt Starter — 5 full assessments per month, $300 each
Up to 95% less per assessment
Same inspection-ready output. Fraction of the cost.
Try first
Try the compliance engine — free, no sign-up
Describe your startup's compliance situation and get a preliminary AI-assisted assessment in seconds. See exactly how the platform structures compliance work before committing to a plan.
No sign-up required
Results in seconds
Preliminary findings and recommendations
Expert follow-up available on request
Talk to us
Discuss your startup's compliance situation with the team
Approaching your first inspection or preparing for investor due diligence? Talk to the RelyAInt team — we'll help you identify the fastest path to a defensible compliance baseline for your specific situation.
Response within 24–48 hours
No obligation or sales pressure
Confidential — your situation stays with us
Platform demonstration available on request
Platform notice: RelyAInt is a self-serve compliance platform. Your team's qualified employees run all assessments and govern all determinations. AI classifies severity and risk — your team confirms every finding before it is published. Expert review by a RelyAInt consultant is available on demand and is billed separately per engagement. All outputs are preliminary and must be confirmed by qualified human reviewers within your organisation.