Expert Regulatory Consulting & Training for Pharma
Helping pharmaceutical and biotech organisations navigate Veeva RIM, IDMP, global submissions, and regulatory digital transformation — with clarity, precision, and real-world experience.
Swapna Bapatla
Regulatory Operations, Systems & Digital Transformation leader specialising in Veeva RIM, IDMP/SPOR, xEVMPD, eCTD submissions, and regulatory technology across EMEA.
Unparalleled Regulatory Expertise,
Practically Applied
Olive Regulatory eSolutions (OReS) Limited is a specialist regulatory consultancy based in the UK, providing expert services to the pharmaceutical industry across the EMEA region.
Founded by Swapna Bapatla — a Regulatory Operations and Digital Transformation leader with over 20 years of pharmaceutical industry experience — OReS brings deep technical knowledge and hands-on delivery capability to every engagement.
Our expertise spans Regulatory Information Management Systems (RIMS), Veeva Vault RIM, IDMP/SPOR, xEVMPD, eCTD publishing, and regulatory digital transformation. We have supported clients including global pharmaceutical companies such as Gilead Sciences and Indivior, delivering complex implementations, migrations, integrations, and training programmes.
We combine strategic consulting with operational delivery — understanding both the regulatory science and the technology that makes it work.
Certifications
Regulatory Systems
Submissions & Standards
Publishing & Validation
Analytics & AI
Specialist Services Across
the Regulatory Lifecycle
From system implementation to submissions management and training — we deliver end-to-end regulatory expertise tailored to your organisation.
RIMS Administration & Implementation
End-to-end Veeva RIM and RIMS implementation, configuration, and ongoing administration.
- Veeva Vault RIM — all modules
- Registrations, Submissions Archive, Content Plans
- Data mapping, migration, and cleansing
- Reports, dashboards, and KPI tracking
- Profiles, security, and access management
- Integration with Planisware, CTMS, eTMF, Quality
- CARA, Liquent Insight, Aris Global, IQVIA RIMSmart
Submissions Management & Publishing
Accurate, compliant regulatory submissions across EMEA — first time, every time.
- eCTD and non-eCTD publishing
- EU, UK, Middle East and Africa submissions
- Baseline, line extensions, and lifecycle variations
- Post-approval quality, labelling & safety variations
- Aggregate reports (PSUR, PBRER)
- Submission tracking and archiving
- Zero validation errors — proven track record
IDMP & xEVMPD
Comprehensive support for ISO IDMP compliance and EudraVigilance data management.
- IDMP awareness and readiness assessments
- xEVMPD submissions and Article 57 maintenance
- SPOR / DADI / PMS data migration and governance
- EV system registration with EMA
- Data cleanup and transfer to PMS
- Veeva Registrations IDMP alignment
- Training on xEVMPD and IDMP processes
Digital Transformation & AI
Modernising regulatory operations through technology, analytics, and intelligent automation.
- Regulatory technology strategy and system selection
- RIM modernisation programmes
- AI-driven automation for regulatory workflows
- Power BI analytics and cross-system reporting
- Process optimisation and data governance
- Integration architecture and vendor management
- WalkMe BOT and in-app guidance
Training & Capability Building
Practical, engaging training that builds lasting regulatory capability within your team.
- Veeva Vault RIM user and admin training
- IDMP, xEVMPD and SPOR awareness
- ICH CTD and eCTD fundamentals
- Post go-live training and adoption programmes
- Quick Reference Guides (QRGs) and SOPs
- Screen recordings and e-learning content
- New joiner regulatory onboarding
Proven Experience Across
Global Pharma Organisations
20+ years of delivery across pharmaceutical, biotech, and consumer healthcare — from large-scale implementations to complex submissions.
Senior Regulatory Operations Consultant / Director
- Veeva RIM implementation (DMS and Content Plans), upgrade, and business process improvements across Regulatory Affairs
- Training roll-out and training material preparation post go-live; RIM enhancements and reporting
- Integration support: Planisware, CTMS, and other in-house tools with Veeva RIM
- IDMP and xEVMPD: Veeva Registrations upgrade to align with EU IDMP, data governance and monitoring
- Advanced Veeva reports and dashboards supporting submission tracking, PSMF Annex H, KPIs, and compliance monitoring
- Actively leveraging AI-driven tools and intelligent automation for regulatory operations efficiency at Gilead Sciences
Senior Manager, Regulatory Operations
- Business Lead and SME for Veeva RIMS, Publishing, and EDMS across EMEA and Global Regulatory teams
- Led Veeva RIMS implementations, migrations, and integrations including data extraction, cleansing, UAT, and deployment
- Directed large-scale migration of 500K+ documents and 6,000+ submissions across Veeva RIMS, EDMS, and publishing platforms
- Strategic oversight of xEVMPD, IDMP (DADI/PMS), IRIS drug shortage reporting, and product registration databases
- System owner and business administrator for regulatory platforms; supported audits, governance, and global process harmonisation
Global Regulatory Operations Consultant
- Managed day-to-day regulatory operations: planning, tracking, publishing, peer review, submission, and archiving (EMEA)
- Delivered high-quality regulatory submissions including Baseline, Line Extensions, Post-approval variations, and Aggregate Reports
- Managed all xEVMPD activities and responded to Article 57 QC team queries
Global Senior Regulatory Systems Specialist
- Lead trainer for Liquent Insight, Documentum, and Publishing systems globally
- Business administrator for RIMS, Documentum, and regulatory databases
- Prepared, published, and submitted dossiers, PSURs, and regulatory documentation
- Led IDMP implementation activities, data governance, and cross-functional coordination
Global Regulatory Systems Consultant
- Led the IDMP implementation project for Global Regulatory Operations
- Managed data collection, workshops, and business process mapping for IDMP readiness
- Identified opportunities to enhance RIMS and improve data governance processes
Regulatory Affairs Consultant → Regional Regulatory Affairs Associate
- Managed regulatory submissions, registrations, renewals, and variations across EMEA and international markets
- Dossier gap analyses, site transfer projects, submission tracking, and regulatory approvals
- Labelling compliance, pharmacovigilance support, and affiliate/HA collaboration
What We Bring to Your Project
Extensive hands-on experience across the full regulatory technology landscape — from enterprise RIMS and document management to health authority portals, analytics, and intelligent automation.
🗂️ Regulatory Information Management
📤 eCTD Publishing & Submission
🌐 Health Authority & Regulatory Portals
📊 Analytics, AI & Collaboration
Planning a Veeva implementation or regulatory transformation?
Let's discuss your project. We bring the experience, the technical depth, and the practical know-how to make it work — first time.
Book a Free Discovery CallLet's Work Together
Ready to talk?
Whether you have a specific project, need a training programme, or want to explore options — reach out and let's have a conversation.