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Veeva Consulting for Regulated Industries. Delivered by People Who Know Them.

From global pharma submissions to food safety compliance, if your industry is regulated and your operations run on Veeva, we have been here before.

Industry Overview

Why do regulated industries need a specialist partner?

Most consultancies treat compliance as a constraint. In regulated industries, it is the foundation everything is built on. From system configurations to data structures, each decision carries implications across GxP, 21 CFR Part 11, and IDMP requirements.

Life Sciences

Pharma | Biotech | Med Tech

From IND to NDA, first-in-human to post-market surveillance, every process depends on technology that is configured correctly, validated thoroughly, and inspection-ready before the auditor arrives. Wolvio is built around this reality.

Regulatory Operations

Getting dossiers to FDA, EMA, PMDA, and regional agencies on time requires a RIM environment that is architected properly from day one.

  • Vault Registrations - global registration lifecycle with automated deadline tracking.
  • Vault Submissions - eCTD authoring, review, and approval aligned to ICH M4 structure.
  • Vault Submissions Publishing - continuous publishing with earlier validation issue detection.
  • Vault Submissions Archive - complete submission history and correspondence tracking.
  • Quality to RIM connection - change events in Vault QMS trigger variation workflows in RIM.

Quality Management

A GxP quality system must hold up in inspection, not only in internal review.

  • Vault QualityDocs - 21 CFR Part 11 and EU Annex 11 document control.
  • Vault QMS - CAPA, deviation, change control, OOS, and batch review with full traceability.
  • Vault Training - role-based GxP training with requalification alerts and audit-ready records.
  • Vault Validation Management - paperless IQ/OQ/PQ with deviation handling and complete evidence.

Clinical Operations

Every eTMF document carries inspection risk and every delay impacts study timelines.

  • Vault eTMF - TMF Bot classification, EDL tracking, and DIA model alignment.
  • Vault CTMS - site management, monitoring, RBM workflows, and issue resolution.
  • Vault Study Startup - country intelligence and site activation progress views.
  • Vault EDC - data capture with Direct Data API integration.
  • Vault Payments - investigator and site payment automation from CTMS data.

Pharmacovigilance and Safety

Expedited reporting windows demand systems configured for speed, accuracy, and complete audit history.

  • Vault Safety - end-to-end ICSR management through global submission.
  • Vault Safety Inbox - automated intake and triage from email, literature, and partners.

Commercial and Medical Affairs

MLR speed and compliance must improve together, not trade off against each other.

  • Vault PromoMats - parallel MLR workflows with full traceability.
  • Vault MedComms - controlled scientific content distribution for medical teams.
  • Vault CRM - field CRM with AI-assisted planning and engagement tracking.
  • Vault Events Management - full HCP event lifecycle in one compliant workflow.

Relevant Case Studies

Real results across regulated industries

Consulting

Global Pharma Co.

Unified Vault RIM architecture for global submissions

Accelerated regulatory submission timelines by consolidating fragmented regional systems into a single Vault RIM instance with automated dossier assembly.

40%

Faster submission cycles

12

Markets integrated

Life Sciences

MedTech Manufacturer

QualityOne rollout with CAPA and supplier governance

Stabilised quality processes across 6 manufacturing sites by deploying QualityOne with standardised CAPA workflows and supplier corrective action portals.

60%

CAPA closure rate improvement

6

Sites unified

Operations

Multi-site Ops Group

Recall readiness and traceability workflow modernisation

Replaced manual spreadsheet-based recall tracking with end-to-end traceability workflows, enabling rapid lot identification across distributed warehouse operations.

3x

Faster lot traceability

100%

Audit trail coverage

Explore case studies
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Serving life sciences exclusively, from day one.

Every Wolvio engagement is led by consultants who understand your regulatory environment, your Veeva platform, and the compliance expectations your organization operates under. Let's talk about yours.

Talk to a Veeva Specialist