DigiM Solution
DigiM Solution provides 3D microstructure imaging and AI-powered analytics software for pharmaceutical companies developing complex drug products, serving 68 pharma partners including top-tier enterprises and the U.S. FDA.
- Company typePrivate
- Founded2014
- HeadquartersBurlington, United States
- Headcount1–10
- GTM typeB2B
- OfferingSoftware
What DigiM Solution does
DigiM Solution LLC is a privately held pharmaceutical microstructure science company founded in 2014 and headquartered in Woburn, Massachusetts. It serves pharmaceutical companies developing complex drug products, including amorphous solid dispersions, oral tablets and capsules, long-acting injectables, implants, and lyophilized products. The company's customer base spans 68 pharmaceutical partners and includes AbbVie, Bristol Myers Squibb, Merck, Moderna, Novartis, Pfizer, Johnson & Johnson Innovative Medicine, Roche, Genentech, Gilead, Lonza, and the U.S. FDA, supporting 189 programs and 1,516 digitized formulations. Its commercial model combines enterprise software subscriptions with performance-based contract research services.
DigiM's platform integrates correlative microscopy (X-ray micro-CT, synchrotron X-ray micro-CT, FIB-SEM, and mosaic SEM) with proprietary AI image analysis, generative AI structure synthesis (sGAN), and in silico dissolution and release modeling to create digital twins of drug products. The software portfolio includes digiM I2S (cloud-based image lifecycle management with FDA 21 CFR Part 11 compliance), dissoLab (dissolution simulation launched January 2025), ivisLab (release prediction for long-acting injectables), and miQ3 (Reference Listed Drug microstructure database supporting ANDA bioequivalence filings). Revenue is generated through multi-year CRO engagements (Baseline Scan, Performance CRO), annual software subscriptions, and integrated platform subscriptions that deliver regulatory-ready CMC packages.
The company's go-to-market is sales-led and consultative, engaging formulation scientists, drug product/CMC teams, and regulatory affairs professionals at enterprise pharma and CDMOs, supplemented by direct sales to FDA divisions through formal procurement. Marketing is content-driven via peer-reviewed publications, case studies, webinars, and conference presentations. DigiM has established formal relationships with three FDA divisions (Office of Pharmaceutical Quality, Division of Product Quality and Research, Office of Generic Drugs), including a research award, an I2S subscription with optional extension to 2028, and Q3 structural equivalence grants.
DigiM Solution firmographics
Firmographics- Name
- DigiM Solution
- Legal name
- DigiM Solution LLC
- Website
- https://digimsolution.com
- Company type
- Private
- Founded year
- 2014
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- DigiM Solution provides 3D microstructure imaging and AI-powered analytics software for pharmaceutical companies developing complex drug products, serving 68 pharma partners including top-tier enterprises and the U.S. FDA.
- Ownership category
- akta.pro rank
DigiM Solution industry classification
Industry- Product category
- Pharmaceutical Drug Development Software
- NAICS
- Computer Systems Design and Related Services (54151), Analytical Laboratory Instrument Manufacturing (334516)
- SIC
- Laboratory Analytical Instruments (3826)
- akta.pro primary industry
- AI/ML Platforms for Drug Discovery & Experiment Optimization (HLAGAJAO)
Keywords
Where DigiM Solution is headquartered
LocationHeadquarters
- HQ city
- Burlington
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
DigiM Solution business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Operations, Infrastructure, Marketing or Sales
Revenue model
- Software Subscriptions: Annual subscription model for digiM I2S, dissoLab, ivisLab, and miQ3 software platforms. Includes cloud-based access with optional local installation for regulatory compliance. Subscription covers specified time periods with optional extensions.
- Platform Subscriptions: Full platform subscription providing comprehensive access to microstructure analysis services and software for scale across clinical trial stages, delivering regulatory-ready CMC packages.
- Performance CRO Services: Contract research organization services including Baseline Scan (initial characterization), Performance CRO (ongoing development support), and custom engagement tiers (3-6 week engagements combining 3D X-ray micro CT imaging and advanced AI analytics).
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Multi-year contract | Baseline Scan - Initial microstructure characterization engagement |
| Subscription | Multi-year contract | Performance CRO - Ongoing development support services |
| Subscription | Annual | Software Subscriptions - Individual software platform access |
| Subscription | Multi-year contract | Platform Subscription - Full integrated platform access |
Go-to-market motion1 record
Distribution channels3 records
Marketing channels6 records
DigiM Solution product offering
Product offeringCore offering
DigiM Solution provides 3D microstructure imaging, AI-powered image analysis, and in silico performance prediction software and services for pharmaceutical drug product development. Its offering combines cloud-based software platforms (digiM I2S, dissoLab, ivisLab, miQ3) with contract research services that use X-ray micro-CT, FIB-SEM, synchrotron, and mosaic SEM imaging alongside proprietary AI analytics to predict dissolution, release, stability, and manufacturability of complex drug products. Customers include formulation scientists, CMC teams, and regulatory groups at major pharmaceutical companies and the FDA.
Product overview
DigiM Solution is a pharmaceutical microstructure science company that offers a platform-plus-services architecture combining proprietary software products with expert analytical services. The core software portfolio includes digiM I2S (cloud-based image processing platform for complete image data lifecycle management), dissoLab (dissolution simulation platform using imaging data), ivisLab (image-based release prediction), and miQ3 (RLD microstructure database for ANDA filings). These software products are complemented by four service offerings: Microstructure Imaging (X-ray micro-CT, FIB-SEM, mosaic SEM), AI Image Analysis, Microstructure Performance Prediction, and Microstructure Quantification. The company also provides solution tiers including Baseline Scan, Performance CRO, Software Subscriptions, and Platform Subscriptions to support pharmaceutical development across all dosage forms including tablets, capsules, implants, microspheres, lyophilized products, and topical formulations.
Differentiator
Problem solved
Functional benefit
Brands
- dissoLab: Cloud-based dissolution simulation platform for pharmaceutical development
- digiM I2S
- ivisLab
- miQ3
Products and services
- digiM I2S Cloud-based image processing platform (Image to Simulation) that manages the complete lifecycle of image data — data management, AI image processing, structural analytics, and image-based simulation. FDA 21 CFR Part 11 compliant with audit capabilities, sold as an annual software subscription to pharmaceutical companies and the FDA.
- dissoLab Cloud-based dissolution simulation platform for pharmaceutical development that uses first-principle dissolution models solved on image voxels to predict dissolution profiles from 3D imaging or generative AI-synthesized 3D volumes.
- ivisLab Image-based release prediction software for long-acting injectable depots. Uses digitized depot morphology and shape attributes to predict drug release profiles for microsphere and depot formulations.
- miQ3 Software solution that supports successful ANDA filings by providing a Reference Listed Drug (RLD) microstructure database for demonstrating Q3 microstructure bioequivalence in generic drug development.
- Microstructure Imaging Correlative microscopy services using X-ray micro-CT, synchrotron X-ray micro-CT, FIB-SEM, and mosaic SEM to create permanent, reusable digital twins of pharmaceutical products. Sold to formulation scientists and CMC teams at pharmaceutical companies.
- AI Image Analysis Proprietary AI image analysis and automation service that quantifies microstructure attributes (particle size, surface area, shape, roundness, porosity, API distribution, coating thickness) as strategic quality levers linking to CQAs and CPPs.
- Microstructure Performance Prediction Service that uses real-world 3D structures, mechanistic models, and generative AI structure synthesis (sGAN) to digitally optimize formulation and process, reducing experiments, time, costs, and risks in drug product development.
- Microstructure Quantification Quantitative analysis service measuring microstructure attributes including porosity, API domain size, particle morphology, and spatial distribution using AI-based analytics to support formulation and process decisions.
Quantifiable outcome
- Reduced dissolution failures and batch-to-batch differences across manufacturing sites
- +3 more outcomes
Companies that use DigiM Solution
Customer profileNamed customers15 records
Segments6 records
Ideal customer profiles2 records
DigiM Solution technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability7 records
Feature6 records
DigiM Solution partnerships and signals
Strategic signalPartnerships
Twelve partnerships are on record, tiered core, major and notable.
- FDA Office of Pharmaceutical Quality (OPQ)coreDigiM received Award #75F40123P00205 from FDA OPQ to characterize and model microstructural quality attributes of drug products. The contract supports OPQ's research in adopting technologies for manufacturing, development, and regulation of complex products including freeze-dried pharmaceuticals, polymeric long-acting products (disks, implants, ocular inserts), and topical foam products.
- FDA Division of Product Quality and Research (DPQR)coreFDA DPQR purchased annual I2S software subscription (PO 75F40123P00369) for assessing impact of material properties and process parameters on product quality attributes. Subscription covers Sept 2023-2024 with optional four-year extension to Sept 2028. Includes local installation on FDA DPQR's in-house cluster with FDA 21 CFR Part 11 compliance.
- AbbViemajorCollaboration on powder mixing indices study using AI analytics with 3D X-ray microCT analysis of agitated filter dryer experiments. Published in Powder Technology journal (doi:10.1016/j.powtec.2023.118273).
- GenentechmajorMultiple co-authored studies including: quantitative analysis of tablet ordered mixing using correlative microscopy-tomography; roller compaction analysis for Avicel MCC formulation; and lyophilization cake characterization. Published in AAPS PharmSciTech and other journals.
- GileadmajorCollaboration on injection rate impact study for long-acting injectable depot dissolution in ex vivo porcine tissue. Examined on-body injector (OBI) system vs traditional autoinjectors, using X-ray micro-CT and image-based release prediction.
- MITnotableJoint project on enteric tablet coating characterization using Micro-CT. Developed methods to interpret tablet compaction mechanisms through 3D representation of microstructural features and numerical simulation of liquid intrusion for dissolution properties.
- NovartisnotableCollaboration on enteric tablet coating study with MIT using Micro-CT characterization methods. Contributed to interpretation of tablet compaction mechanisms and coating impact on release performance.
- University of ConnecticutnotableCollaboration on aging-induced microstructural evolution in risperidone loaded PLGA microspheres. Study used correlative FIB-SEM and XRM to quantify structural changes as function of aging.
- Janssen (Johnson & Johnson)majorCollaboration on synchrotron computed tomography combined with AI-based image analysis for advanced characterization of spray dried amorphous solid dispersion particles. Published in Journal of Pharmaceutical Sciences.
- Ghent UniversitynotableCo-authored synchrotron CT study for spray dried ASD particle characterization with researchers from Ghent University.
- Indian Institute of Technology MadrasnotableCollaboration on powder mixing study using AI analytics with AbbVie and IIT Madras researchers. Applied 3D X-ray microCT analysis to evaluate mixing performance in agitated filter dryer.
- FDA Office of Generic Drugs (OGD)coreResearch grants from FDA OGD for assessing Q3 structural equivalence supporting generic drug development. Part of continued efforts to develop integrated feedback loop between industry and regulatory bodies.
Scale indicators4 records
Recent moves6 records
Expansion highlights6 records
DigiM Solution competitors and assessment
Company assessmentDirect peers
- Simulations Plus: Simulations Plus provides modeling and simulation software for pharmaceutical R&D including physiologically-based pharmacokinetics and QSP, directly overlapping with DigiM's in silico drug product performance prediction business.
- Certara: Certara offers biosimulation and regulatory science software used across the pharma development lifecycle, sharing the same enterprise-pharma buyer as DigiM's microstructure analytics platform.
- Schrödinger: Schrödinger operates a physics-based computational platform for drug discovery and development, competing for the same enterprise pharma R&D IT wallet that DigiM addresses through structure-based simulation software.
- Genedata: Genedata provides scientific informatics platforms for biopharma R&D including screening and process development workflows — closely adjacent to DigiM's image-based formulation informatics stack.
Broad incumbents
- Molecular Devices: Molecular Devices (Danaher) supplies a broad portfolio of analytical lab instruments and software for pharmaceutical and biotech research, providing overlapping analytical capabilities to pharma R&D customers served by DigiM.
- Unchained Labs: Unchained Labs offers analytical tools that accelerate biologics and formulation development across stability, viscosity and particle characterization, partially overlapping with DigiM's microstructure quantification use cases.
- Eurofins Discovery: Eurofins Discovery is a large CRO offering drug discovery and preclinical services, representing an alternative engagement model for pharma companies that may use DigiM's specialized microstructure analytics today.
- Charles River Laboratories: Charles River is a major preclinical and contract research organization serving the same top-20 pharma accounts as DigiM, with overlapping formulation and analytical services capabilities.
Others
- Carl Zeiss Microscopy: Zeiss is a leading manufacturer of X-ray microscopy and correlative microscopy systems that DigiM's services rely on; Zeiss could integrate competing AI analytics or partner more deeply with rivals, materially affecting DigiM's hardware-software economics.
- Bruker: Bruker manufactures X-ray micro-CT and other analytical instruments used by DigiM, and through its pharma software portfolio is a potential adjacent competitor in microstructural drug-product analytics.
Market position
Strengths5 records
Weaknesses4 records
Competitive moat5 records
Key risks5 records
Key highlights7 records
Customer concentration
DigiM Solution social profiles
Digital presenceDigiM Solution compliance and trust
Trust signalCompliance1 record
DigiM Solution financial estimates
Financial estimateRevenue estimate
Valuation estimate
DigiM Solution leadership team
Management profileNumber of profiles
Profiles2 records
DigiM Solution funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
DigiM Solution M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about DigiM Solution
What does DigiM Solution do?
DigiM Solution provides 3D microstructure imaging, AI-powered image analysis, and in silico performance prediction software and services for pharmaceutical drug product development. Its offering combines cloud-based software platforms (digiM I2S, dissoLab, ivisLab, miQ3) with contract research services that use X-ray micro-CT, FIB-SEM, synchrotron, and mosaic SEM imaging alongside proprietary AI analytics to predict dissolution, release, stability, and manufacturability of complex drug products. Customers include formulation scientists, CMC teams, and regulatory groups at major pharmaceutical companies and the FDA.
Is DigiM Solution a public or private company?
DigiM Solution is a private company. It is classified as unknown and is currently operating.
When was DigiM Solution founded?
DigiM Solution was founded in 2014. It employs 1 to 10 people.
Where is DigiM Solution based?
DigiM Solution is headquartered in Burlington, United States, in the North America region.
How does DigiM Solution make money?
Three revenue lines are on record. Software Subscriptions are the primary driver. The others are platform Subscriptions and performance CRO Services.
Who are DigiM Solution's main competitors?
Direct peers on record are Simulations Plus, Certara, Schrödinger and Genedata. Broad incumbents are Molecular Devices, Unchained Labs, Eurofins Discovery and Charles River Laboratories. Others are Carl Zeiss Microscopy and Bruker.
Does DigiM Solution have an API?
No public API is recorded for DigiM Solution.
What industry is DigiM Solution in?
DigiM Solution's product category is Pharmaceutical Drug Development Software. Its primary akta.pro industry code is HLAGAJAO, AI/ML Platforms for Drug Discovery & Experiment Optimization. Its NAICS code is 54151 and its SIC code is 3826.