IntelaSolve Solutions
12
Global Regulatory Markets
12
Regulatory Lifecycle Phases
1
Source of Truth

For established life sciences companies

A single compliance platform for your entire regulated portfolio.

Multiple products. Multiple sites. Every major jurisdiction. Replace the point-solution stack — QMS, PLM, EPDM, ERP/MRP, clinical trial, and regulatory tools — with one compliance infrastructure platform. Purpose-built for mature life sciences operations and the auditors and notified bodies you answer to.

See the platform

The IntelaSolve™ Lifecycle Framework

Twelve lifecycle areas.One connected Platform.

1Concept2Reg Strategy3Pre-Sub4Quality System5Design & Dev6Clinical7Tech Docs8Submission9Manufacturing10Launch11PMS & CAPA12Sustaining / EOLINTELASOLVE™Lifecycle Framework1 → 12, continuously connected

Click any number to see what that phase covers.

Built for scale

A platform that respects how mature life sciences companies actually operate.

  • 01

    Multi-product, multi-site

    Manage portfolios across business units, manufacturing sites, and product families — with shared controls and isolated workspaces where you need them.

  • 02

    Role-based workflows

    Granular permissions, electronic signatures, and review routing built for large RA, QA, Clinical, and Manufacturing teams — not retrofitted from a founder tool.

  • 03

    Harmonized global submissions

    Reusable submission cores across FDA, EU MDR/IVDR, Health Canada, PMDA, TGA, ANVISA, MDSAP, and CE — submit faster into every market you operate in.

  • 04

    Post-market at scale

    High-volume complaint intake, vigilance reporting, NCR, CAPA, field actions, and PSUR — with traceability all the way back to design and risk.

  • 05

    Migrate from legacy systems

    Structured migration paths from incumbent quality, regulatory, and complaint systems — preserve audit history while moving to a modern, connected compliance infrastructure.

  • 06

    Audit & inspection ready

    Every record, signature, and revision captured with the traceability auditors, notified bodies, and FDA inspectors expect.

Jurisdictions & Regulatory Frameworks

Support across 12 major regulatory markets.

IntelaSolve™ supports Life Sciences teams in organizing Quality, regulatory, clinical, technical documentation, and post-market evidence in alignment with leading global authorities and frameworks.

Flat world map showing IntelaSolve™ coverage across 12 major regulatory markets.

  • United States

    FDA

    US

    Title 21 CFR, cGMP, GxP, QMSR, MDSAP where applicable

  • Canada

    Health Canada

    CA

    Food and Drugs Act, Medical Devices Regulations, GMP, GxP, MDSAP

  • United Kingdom

    MHRA

    UK

    UK medicines and medical device regulations, GxP, UKCA

  • European Union

    European Commission, EMA, national competent authorities

    EU

    EU MDR, EU IVDR, EU pharmaceutical legislation, GxP, CE Marking

  • Brazil

    ANVISA

    BR

    Brazilian health regulatory framework, GMP, GxP, MDSAP where applicable

  • Japan

    MHLW / PMDA

    JP

    PMD Act, Japanese QMS and GxP expectations, MDSAP where applicable

  • Australia

    TGA

    AU

    Therapeutic Goods framework, GMP, GxP, ARTG, MDSAP where applicable

  • South Korea

    MFDS

    KR

    Korean Life Sciences regulatory framework, KGMP, GxP

  • Singapore

    HSA

    SG

    Health Products Act, medical device and therapeutic product framework, GxP, MDSAP observer

  • Switzerland

    Swissmedic

    CH

    Therapeutic Products Act, Swiss medical device and IVD ordinances, GMP, GxP

  • Mexico

    COFEPRIS

    MX

    Mexican health regulatory framework, GMP, GxP, MDSAP affiliate

  • Taiwan

    TFDA

    TW

    Taiwanese Life Sciences regulatory framework, GMP, GxP, MDSAP affiliate

IntelaSolve™ supports alignment with these frameworks. Specific submission pathways and product-class requirements are addressed within each engagement.

Replace the patchwork

Stop stitching together QMS, PLM, EPDM, ERP/MRP, and clinical trial software.

Life sciences teams accumulate point solutions the same way they accumulate products. IntelaSolve™ replaces the patchwork with one connected compliance infrastructure platform.

Today

A patchwork of point solutions

  • Standalone QMS for documents, CAPA, and training
  • Separate PLM for design history and configuration
  • Disconnected EPDM for product data and BOMs
  • ERP/MRP bolted on for manufacturing and supply
  • Point clinical trial software for study management
  • Standalone vigilance and complaint tools
  • Spreadsheets, email, and shared drives for the rest

With IntelaSolve™

One compliance platform

  • One platform across design, risk, and manufacturing
  • Reusable submission cores for every jurisdiction
  • Integrated complaints, MDR/vigilance, and CAPA
  • Living traceability from requirement to field
  • Auditable agency interaction history
  • Forward and backward traceability from Clinical to post-market data and back.

Markets we serve

See how IntelaSolve™ supports your regulatory market

Pharmaceutical, medical device, combination product, and global submission programs.

Explore markets