For founders & first-time submitters
The entire regulatory lifecycle, engineered for founders building their first regulated product.
From regulatory strategy and pre-submission meetings to clinical trials, global submissions, quality systems, and post-market surveillance — IntelaSolve™ unifies the work that early-stage life sciences teams otherwise stitch together across separate QMS, PLM, and clinical trial point solutions, consultants, and spreadsheets.
Click any phase to explore details.
Who it's for
Built for the founder filing their first 510(k), CE mark, or IDE.
"Most compliance tools assume you already have a Director of RA, a QA team, and three external consultants. IntelaSolve™ assumes you don't — and gets you to submission anyway."
- 01
First regulated product
Built around the realities of getting a Class II device, IVD, or SaMD through its first submission — not retrofitted from enterprise compliance suites.
- 02
Lean teams
A platform that a founder, RA lead, or fractional QARA consultant can actually run — without an admin army.
- 03
Investor-ready posture
Audit-ready artifacts, real traceability, and a defensible regulatory narrative for partners, acquirers, and diligence teams.
Complimentary for founders
Get your Compliance Readiness Analysis — now.
A short, structured questionnaire pinpoints where you are across the 12 phases of the regulatory lifecycle and returns a recommended timeline for implementing IntelaSolve™ — tailored to your product class, target markets, and submission date.
Take the Readiness Analysis
Start nowDay one, not year one
Purpose-built compliance infrastructure, deployed to your company in 8 weeks.
For founders, IntelaSolve™ isn't a generic toolkit you assemble. We deploy a compliance infrastructure platform tailored specifically to your company and your product(s) — globally compliant and ready to use on day one.
From kickoff to go-live in 8 weeks. No multi-year platform build. No piecing together templates from five consultants.
You get a fully operational quality system with every procedure, work instruction, and workflow pre-configured to your scope — including post-market surveillance, complaints handling, vigilance, and CAPA — so your team can generate audit-ready evidence from the very first day in production.
Validation, training, and go-live support are included. We execute Computer Software Assurance (CSA), verify 21 CFR Part 11 and EU Annex 11 controls, and train your quality, regulatory, clinical, and operations teams on the workflows they will own.
- Purpose-built compliance infrastructure tailored to your company and product(s)
- Post-market surveillance content pre-loaded and ready to run
- Global compliance baseline: FDA, EU MDR/IVDR, MDSAP, Health Canada, and more
- Procedures, work instructions, integrated training, automated workflows that generate records and evidence automatically ... all aligned to your device and pathway.
- Design & development, risk management, and CAPA workflows wired end-to-end
- Document control, records, and training aligned to your device and regulatory pathway
- Configured roles, user management, platform set-up and validation
- Audit-ready traceability and inspection readiness from the moment you go live
Week 1
Discovery & scoping
We capture the inputs needed to configure your platform to your company, your products, and your regulatory pathway.
- Company profile, team structure, and current QMS state captured
- Product(s), intended use, and device classification confirmed
- Target markets and regulatory pathway (FDA, EU MDR/IVDR, MDSAP, Health Canada) locked
- Implementation plan, milestones, and named owners agreed
Weeks 2–3
Tailored build
Your compliance infrastructure and post-market content are configured to your company and products.
- QMS procedures, work instructions, and forms configured to your scope
- Design controls, risk management, and CAPA workflows wired end-to-end
- Post-market surveillance, complaints, and vigilance content pre-loaded
- Document control, training, and records aligned to your device and pathway
Weeks 4–7
Validation & training
We validate the platform to GxP expectations and train your team on the workflows they will own from day one.
- Computer Software Assurance (CSA) executed with documented evidence
- 21 CFR Part 11 and EU Annex 11 controls verified for electronic records and signatures
- Role-based training delivered to quality, regulatory, clinical, and operations
- Procedural and workflow walkthroughs completed with your named system owners
Week 8
Go-live
Production cutover to a globally compliant infrastructure with post-market operations live from the first day in production.
- Production environment released with full audit trail enabled
- Live workflows generating records and objective evidence automatically
- Internal audit and management review cadence scheduled
- Submission-ready documentation and inspection readiness package in hand
Supporting alignment across 12 major regulatory markets
- USUnited States
- CACanada
- UKUnited Kingdom
- EUEuropean Union
- BRBrazil
- JPJapan
- AUAustralia
- KRSouth Korea
- SGSingapore
- CHSwitzerland
- MXMexico
- TWTaiwan
Why IntelaSolve™
A compliance platform that respects how regulated products are actually built.
Built by people who have submitted, defended, and remediated real programs — not by a generic GRC vendor adding life-sciences templates as an afterthought.
- 01
One platform, not a point-solution stack
QMS, PLM, EPDM, ERP/MRP, clinical trial, and regulatory tools unified into one connected infrastructure — no integrations, no data silos, no reconciliation.
- 02
Founder-friendly workflows
Sensible defaults, guided pathways, and templates calibrated for first-time submitters — not enterprise admins.
- 03
Audit-ready by design
Every record, signature, and revision is captured with the traceability auditors and notified bodies expect.
- 04
Global from day one
Reusable submission structures for FDA, EU MDR/IVDR, Health Canada, PMDA, TGA, ANVISA, MDSAP, and CE Marking.