Data with Purpose:
Reliable Regulatory
Database Management
Solutions for the
Life Sciences Industry
Structured Regulatory Values
We accompany pharmaceutical, biotech and life sciences companies operating in South Africa or expanding into Europe through IDMP readiness, implementation and regulatory data compliance - bridging local regulatory realities with EU IDMP and global standards.
We translate complex international requirements into practical, locally relevant solutions, ensuring your data is accurate, structured and future-ready.
Whether you are preparing for future regulatory convergence, aligning cross-border operations, or reducing long-term compliance risk, early and informed IDMP alignment creates lasting value.
A focused conversation today can prevent costly remediation tomorrow.
More DetailsKey Value Strengths
IDMP Without the Overwhelm
From gap assessments to full implementation, we make IDMP achievable - without unnecessary complexity or system lock-in.
Local Regulatory Reality, Global Alignment
We align SAHPRA-facing data requirements with EMA, EU IDMP and international standards.
Vendor-Neutral, Data-First Approach
We work with your existing systems - or help you select the right ones - always prioritising data quality and ownership.
Built for Cross-Border & Future Regulation
Our IDMP approach is designed to work across jurisdictions - supporting today’s South African regulatory needs while preparing your data for European and global regulatory convergence.
More DetailsIDMP-Ready. Regulation-Ready. Data That Works.
Bridging South African life sciences data with global IDMP standards.
IDMP Readiness, Gap Assessments & Analyses
A clear, practical analysis and assessment of where your data stands against ISO IDMP - and what to fix first.
Regulatory Data Modelling & Governance
We design structured, governed data models that support compliance today and scale for tomorrow.
Substance, Product & Referential Data Structuring
Transform fragmented regulatory information into consistent, IDMP-aligned datasets.
System Selection & Implementation Support
Independent guidance to ensure your systems support IDMP - without unnecessary complexity or vendor lock-in.
Ongoing IDMP Operations & Training
Practical support and training to keep your IDMP data accurate, current and audit-ready.
Partner & Data Ecosystem Onboarding
Structured onboarding of internal teams, vendors and partners to ensure consistent, IDMP-aligned data across your ecosystem.
Our process in five simple steps
1
Assess
Assessment & Scope
We assess your current regulatory data landscape, identify IDMP gaps, and define a realistic scope aligned to your products, markets and regulatory obligations.
2
Design
Target Data Model
We design an IDMP-aligned target data model, including products, substances, referential data and governance - tailored to your organisation and systems.
3
Structure
Remediate & Structure Data
Existing data is cleaned, standardised and structured to meet IDMP requirements, creating a reliable single source of regulatory truth.
4
Enable
Enable Systems & Processes
We align systems, workflows and responsibilities to support ongoing IDMP data maintenance - without unnecessary system changes.
5
Operate
Governance & Improvement
Operationalisation through governance, training and continuous improvement to keep IDMP data accurate, compliant and future-ready.
Start Your IDMP Journey with Confidence
Book a confidential consultation to assess your current readiness and next steps.
Experience nestled in 30+ years'
bespoke guidance, solutions and project management.
See our Case Studies
