Volody partners with SMBC, LexisNexis & AMT to Shape the Future of Legal AI - Read Press Release →

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Volody partners with SMBC, LexisNexis & AMT to Shape the Future of Legal AI - Read Press Release

Volody partners with SMBC, LexisNexis & AMT to Shape the Future of Legal AI- Read Press Release

Pharma Leader Achieves 95% Compliance & 84% Faster Cycles

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95%

Compliance Risk Reduction

84%

Faster Contract Cycles

$12.4M

Annual Cost Savings

1.5K+

Contracts Managed

Executive Summary

A Fortune 100 pharmaceutical manufacturer was struggling to manage contracts across FDA, EMA, Health Canada, and 40+ international regulatory bodies, with approval processes fragmented across jurisdictions and no centralized repository for critical contract terms. This created serious compliance vulnerabilities, cost the company an estimated $18.7M annually, and stretched contract processing to 145 days against a 90-day industry benchmark.

Volody built a pharmaceutical-grade CLM platform designed around global regulatory compliance, AI-powered risk detection, and standardized workflows across legal, regulatory, quality, and manufacturing teams. Deployed in just 12 weeks, the platform reduced compliance risk by 95%, cut contract processing time by 84%, and delivered $12.4M in annual savings while achieving full audit readiness.

Problem Statement

Global Regulatory Complexity Was Outpacing Contract Operations

As a pharmaceutical manufacturer operating across 60+ countries, the organization had to manage contracts against the requirements of FDA, EMA, Health Canada, and 40+ other regulatory bodies. Approval processes were fragmented across jurisdictions, contract terms were scattered with no centralized repository, and there was no reliable way to track contractual obligations. This left the organization exposed to compliance risk and made audit readiness a constant struggle.

The Challenge

Fragmented Processes Put Regulatory Compliance at Risk

The lack of a unified system meant contract processing stretched to 145 days on average, well above the 90-day pharmaceutical industry benchmark, while compliance inefficiencies and regulatory delays cost the organization an estimated $18.7M each year. Manual tracking of contractual commitments created ongoing compliance risk, and 67% of audits required extensive manual documentation gathering just to demonstrate compliance.

Communication gaps between legal, regulatory, and business teams made it difficult to maintain unified oversight, leaving the organization without the visibility it needed to manage risk at scale.

Key Challenges were:

Approval processes were fragmented across multiple regulatory jurisdictions

1

2

Contract requirements varied across FDA, EMA, and 40+ regulatory bodies

Contract terms remained scattered with no centralized repository

3

4

Contractual obligations were tracked entirely manually, creating compliance risk

Legal, regulatory, and business teams still lacked truly unified oversight

5

6

Audits required extensive manual documentation gathering

1

Approval processes were fragmented across multiple regulatory jurisdictions

3

Contract terms remained scattered with no centralized repository

5

Legal, regulatory, and business teams still lacked truly unified oversight

2

Contract requirements varied across FDA, EMA, and 40+ regulatory bodies

4

Contractual obligations were tracked entirely manually, creating compliance risk

6

Audits required extensive manual documentation gathering

In a regulatory environment this complex, even small gaps in visibility could translate into significant compliance penalties and delayed product approvals - making a unified, audit-ready platform essential.

The Solution

A Pharmaceutical-Grade CLM Built for Global Compliance

Volody was chosen for its proven experience with global pharmaceutical manufacturers and its ability to handle sensitive regulatory documentation at enterprise scale. The platform was built to support compliance frameworks across FDA, EMA, ICH, and other international pharmaceutical regulations, while integrating with the organization's existing manufacturing and quality systems.

Regulatory mapping & integration: Assessed global compliance requirements and connected the CLM to existing pharmaceutical manufacturing and quality systems.

Legacy contract migration: Used AI to review, classify, and migrate 1,500+ existing pharmaceutical agreements with regulatory metadata extraction.

Standardized workflows: Built approval processes tailored to different contract types while maintaining consistent global compliance.

Regulatory template libraries: Provided pre-approved contract templates meeting FDA, EMA, and international pharmaceutical standards.

Automated compliance monitoring: Tracked regulatory obligations and contractual commitments in real time.

AI-powered risk detection: Flagged compliance risks and surfaced pharmaceutical-specific insights through advanced analytics.

See how Volody helped a top e-commerce retailer streamline its contract management.

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Implementation

A Rapid 12-Week Rollout Across Legal, Regulatory, and Manufacturing Teams

Implementation was completed in 12 weeks across three phases, moving from regulatory assessment and system integration to workflow standardization and finally advanced AI deployment.

The implementation process involved:

Regulatory Mapping → System Integration → Legacy Contract Migration → Workflow Standardization → Template Library Setup → Compliance Monitoring Configuration → AI Risk Detection Deployment → Training & Go-Live

A key part of the implementation was migrating 1,500+ legacy pharmaceutical agreements into Volody, with automated metadata extraction for faster classification and retrieval.

The implementation team worked closely with legal, regulatory, quality, and manufacturing stakeholders to ensure the platform met pharmaceutical-grade security and audit requirements while minimizing disruption to critical operations.

Compliance used to mean digging through scattered files every time an audit came up. Now everything is in one place, tracked automatically, and ready whenever we need it. That shift alone has changed how our legal and regulatory teams work together.

- Global Compliance & Contracts Lead

The Result

95% Less Compliance Risk and 84% Faster Contract Cycles

The new platform gave the organization a centralized, audit-ready system for managing contracts across 60+ countries and 40+ regulatory bodies. Contract cycle times dropped dramatically, compliance risk fell sharply, and the legal and regulatory teams gained the visibility needed to track obligations and stay ahead of audits.

Key Outcomes:

95% Less Compliance Risk

Achieved comprehensive regulatory adherence across all jurisdictions

84% Faster Cycles

Cut contract processing time from 145 days to 23 days

$12.4M Cost Savings

Achieved through operational efficiency and compliance optimization

1,500+ Contracts Unified

Brought the entire pharmaceutical portfolio onto one platform

100% Audit Readiness

Maintained complete documentation for pharmaceutical regulators

Stronger Cross-Team Visibility

Connected legal, regulatory, quality, and manufacturing teams.

About the Client

A Fortune 100 pharmaceutical manufacturing powerhouse and the world's largest integrated supplier of solid dosage products, producing over 130 billion capsules annually across 60+ countries. The company serves major pharmaceutical companies through advanced manufacturing, packaging, and inspection technologies, backed by more than 60 years of industry leadership.

Company Size: $3.2+ Billion Revenue

Industry: Manufacturing, Pharmaceutical

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