Makana Pharma Content Management dashboard showing AI claims matching, work items, watchlist metrics, and Slack integration.
Coming soon

Regulated Content Management

What if compliance wasn't the last thing you checked? Regulated Content Management proactively embeds compliance and content intelligence directly into the moment of creation. Every claim is validated, every obligation is verified, and every asset arrives at MLR review-ready, all while content creation is simplified with agent-assisted authoring.

Scale content creation and management

Track in-progress content, compliance alerts, and tasks in a persona-specific Command Center for every role in the content lifecycle: compliance ops, creators, reviewers, approvers, and auditors.

Makana Pharma dashboard: 9 SLA-overdue reviews, 23 pending items, 54% first-pass rate, 8 work items, rising signature times

Reduce manual edits with agent-assisted content refinement, and quality and compliance checks against approved claims and brand guidelines, so every asset is compliant before reaching review.

Makana Pharma Content AI Studio: managing HCP Clinical Profile content with linked claims and an ONCURA patient communication preview.

Makana Pharma Content Management filtered by Immunexis, Draft status, and content types, showing Drug Emailer and Video Ad results.

Makana Pharma Content Management filtered by Immunexis, Draft status, and content types, showing Drug Emailer and Video Ad results.

Track content usage, compliance metrics, and process KPIs, like average time in draft. Get actionable insights to improve content creation process and quality.

Makana Pharma dashboard: 42 versions submitted (-15%), 71% utilization (+5%), plus compliance violations and review lifecycle charts.
Makana Pharma dashboard: 9 SLA-overdue reviews, 23 pending items, 54% first-pass rate, 8 work items, rising signature times
Makana Pharma Content AI Studio: managing HCP Clinical Profile content with linked claims and an ONCURA patient communication preview.
Makana Pharma Content Management filtered by Immunexis, Draft status, and content types, showing Drug Emailer and Video Ad results.
Makana Pharma dashboard: 42 versions submitted (-15%), 71% utilization (+5%), plus compliance violations and review lifecycle charts.

Keep every asset compliant and market-ready

Link every claim to its reference and substantiation, maintained in a central repository for reusability and searchability. AI agents suggest matches from your approved library, identify missing claims, and harvest new ones.

Makana Pharma tool: Extract & Match Claims found 27 claims, tracking downstream asset impacts and expiry dates.

Manage regulatory and legal obligations by content type, market, and channel, with manual extraction and annotation on reference documents. Surface relevant obligations in a checklist like important safety information, fair balance, unique device identification (UDI), channel placements, and brand checklists through content metadata.

Makana Pharma content interface: Immunexis efficacy email with a Workflow panel for compliance checks against UK SmPC and ABPI info.

Get a calculated compliance score based on claims substantiations, obligations for channel and country, quality control, and brand guidelines so updates can be made before review.

Makana Pharma review of Immunexis Efficacy Email_HCP: AI flags 35% confidence score, citing a misleading 88% symptom relief claim.

Connect claims, evidence, references, obligations and content as structured data rather than static assets, streamlining compliance management from content creation to claim expiration across every product and region.

Makana Pharma Regulated Claim Statement 0001 page with a "Find References" overlay showing AI-suggested sources for medical claims.
Makana Pharma tool: Extract & Match Claims found 27 claims, tracking downstream asset impacts and expiry dates.
Makana Pharma content interface: Immunexis efficacy email with a Workflow panel for compliance checks against UK SmPC and ABPI info.
Makana Pharma review of Immunexis Efficacy Email_HCP: AI flags 35% confidence score, citing a misleading 88% symptom relief claim.
Makana Pharma Regulated Claim Statement 0001 page with a "Find References" overlay showing AI-suggested sources for medical claims.

Publish approved content to any channel

Publish content across multiple channels in just a few clicks, including Agentforce Life Sciences, web, and Salesforce CMS, and activate in email, digital, portals, and more, with Agentforce Marketing.

Built as an open, compliant foundation that works with existing DAMs, CMS, authoring platforms, and downstream channels, RCM provides compliance intelligence across content, without locking teams into a single system.

Makana Pharma "Publish to CMS" step 3: two "Promotional emailer to KOL" zip files ready to publish to a Salesforce CMS folder.

Group related assets into versionable, hierarchical collections with expected content placeholders and completeness checks, then track exactly where every asset is used across channels and markets.

Makana Pharma Cardiolex 50mg Regulatory Package: document sidebar with localized versions and Template Requirements status tracker.
Makana Pharma "Publish to CMS" step 3: two "Promotional emailer to KOL" zip files ready to publish to a Salesforce CMS folder.
Makana Pharma Cardiolex 50mg Regulatory Package: document sidebar with localized versions and Template Requirements status tracker.

Eliminate review and audit bottlenecks

Pre-configured 21 CFR Part 11-compliant reviewer workflows based on content tiers keep review cycles moving with status tracking to accept, reject, or propose new claim linkages and finalize with digital signatures.

Capture action across the full content lifecycle from creation, edits, annotations, approvals, to downloads so it's searchable and audit-ready.

What's ahead for Regulated Content Management

Available for Early Adopters (October '26) November '26 - February '27 Beyond February '27
Agentic Claims Extraction Claims Command Center BYO DAM
Substantiation Intelligence Agentic Content Creation (Pilot) Agentic Content Creation (GA)
Tiered MLR Review Agentic Tier Review Office 365 Integration
Obligations Management Agentic Obligations Checks Headless 360
Persona-Based Command Center Content Collections Contentful Integration
Submission Readiness Agent Digital Review Auto Classification (incl. metadata)
...and more! ...and more! ...and more!

Keep up with the latest regulated content trends and insights

Regulated Content Management FAQs

Regulatory content management is a system that embeds compliance directly into the content creation process. It helps life sciences companies ensure marketing and medical materials meet regulatory standards before reaching final review. This proactive approach accelerates bottlenecks, reduces rework, and speeds up time to market.

Regulated Content Management will be accessible to early adopters in October 2026. It will be generally available for purchase in early 2027. If you're interested in being an early adopter, reach out to your account team.

It catches compliance issues during the drafting phase rather than at the end of the cycle. By using AI agents to validate claims, check references, and ensure brand alignment early on, materials arrive at the Medical, Legal, and Regulatory (MLR) review stage fully prepared. This eliminates prolonged back-and-forth edits.

AI agents assist writers by automatically extracting metadata, verifying claims against approved libraries, and checking for quality errors. These tools proactively identify expiring claims and missing references during authoring. This ensures all content is accurate, compliant, and ready for distribution much faster.

Yes. A modern platform uses an open architecture that integrates seamlessly with your existing Digital Asset Management (DAM) systems. This allows organizations to sync approved content across current tools and channels without needing a costly migration or redundant approval processes.

The system captures a secure, immutable audit trail across every touchpoint of the content lifecycle. It records creation details, edits, user actions, and timestamps. This centralized tracking ensures organizations remain fully prepared for regulatory inspections and adhere strictly to 21 CFR Part 11 guidelines.

Compliance intelligence structures claims, references, obligations, and content relationships as interconnected data. This architecture allows the system to easily analyze content across multiple channels. It surfaces expiring claims and ensures compliance logic is embedded directly into the daily workflow.

Chief Compliance Officers benefit from reduced risk and faster cycles. Marketing and Medical Affairs teams experience quicker content creation with fewer revisions. Additionally, IT leaders appreciate seamless integration capabilities that do not disrupt existing digital asset infrastructures.

Legacy processes treat compliance as a final checkpoint, which often leads to costly rework and delayed launches. Proactive compliance embeds regulatory checks directly into the initial authoring stage. This prevents violations early, ensuring every asset is fully audit-ready by default.

Yes, MLR is just the first use case that Regulated Content Management supports. There is wide applicability across the life sciences industry and beyond, inclusive of medical and clinical use cases.