QC Automation Solutions

DDi drives operational quality with automation solutions designed for BioPharma and Medical device companies. For over 8 years, our QC solutions reduce cycles, cut over 70% of manual efforts, boost consistency, minimize error margins, and safely speed up turn-around-time across all functions (Clinical, CMC, Non-Clinical, Labelling, Tech Documentation, Quality).

REGai does this in 3 ways (based on Client Preference and Use Cases):

Zero AI solution (Rule-based)
AI solution (with local models and no 3rd party AI connectors needed)
Hybrid

Explore Capabilities

Automating Quality Control (QC)

Deploying smart automation to reduce cycle latencies, improve consistency and minimize
structural operational risk.

Consistency Checks

Ensure terminology, values, abbreviations, citations, and references remain consistent across lengthy dossiers and multiple files.

Compliance Verification

Automatically compare content against global regulatory expectations and internal quality standards seamlessly.

Faster Review Cycles

Identify issues early and recommend corrections automatically, helping teams achieve right-first-time submissions.

Style Guide Application

Instantly apply pre-configured corporate or regulatory templates to raw text to ensure brand and agency alignment.

Word and PDF checks

a Library of over 600 checks covering formats to grammar tables checking to layouts to TOC/bookmarks/hyperlinks and more

Auto-Fix

Don’t stop with QC. Select Auto-Fix option to fix word and pdf when rrors found to save time further.

QC Automation Solutions

Pharma / Biotech

Regulatory Affairs

DDi’s sophisticated QC automation eliminate errors in global regulatory dossiers, verifying dynamic submission workflows, enforcing cross-regional compliance, and ensuring absolute pinpoint precision.

Publishing

Streamline regulatory publishing compilation with automated validation setups. Efficiently check hyperlinks, text formatting, font properties, bookmark loops, and eCTD structure criteria rapidly.

Medical Writing

Automate tedious quality checks on technical, clinical, and scientific scripts. Instantly evaluate structured style guidelines, complex reference listings, and table data consistency.

Labeling

Optimize tracking metrics and prevent content drift across dynamic safety updates, package graphics, and local label definitions using systemic cross-comparisons.

CMC

Ensure high-level cross-document alignment across critical CMC authoring drafts, data summaries, product certificates, safety inserts, and global requirements simultaneously.

Medical Device

Tech Documentation Automation

Optimize technical file compilation structures securely using agentic AI loops. Reduce validation lifecycles for MDR/IVDR compliance protocols and optimize product data accuracy levels.

Label QC Automation

Leverage automated AI structures to rapidly cross-examine device labels, UDI structures, manufacturing signs, and clinical instruction text with strict regulatory frameworks seamlessly.

Clinical

Accelerate extensive clinical evaluation report reviews using intelligent automation. Validate raw medical metrics safely against core trial evidence documents without error margins.

How can you use REGai QC solutions ?

REGai Tool
(UI Interface)

Checks/Rules & parameters setup, (mapping diff checks to diff type of documents), file upload, run jobs instantly, download updated files

MS Word / 365

Plugins /add ins are provided with customized ribbons to perform fixes while in the document

Hybrid

Some steps done by batch while other steps done interactively (like updating hyperlinks manually) or changing parameters and re-run jobs

Your Current tools
(with interface)

With interface to your current EDMS/RIM, batch scheduling can be done (hourly, daily)

Pull files, Auto Fix/QC and upload back to Source (either check-in or create folders)

Security & Privacy

Enterprise-grade security architectures
ensuring total privacy and data control.

It never trains on your data

REGai uses pre-trained AI models hosted on a private system, not public ones like ChatGPT, Claude etc. Your firm’s data is never used to improve the model or shared with others. We also use a secure, private connection between our systems, ensuring data is never exposed to public internet traffic or 3rd Party systems via APIs.

It lives inside DDi’s secure environment

Everything stays inside our SOC 2 Type 2-compliant infrastructure with encryption, role-based access controls, and other enterprise-grade security features. This keeps your data secure and reduces the number of vendors touching it, which means simpler compliance workflows and stronger control.