Regulatory Built for Control and Condifence
Build a regulatory function that delivers timely submissions, reliable product data and steady compliance. Supported by consultants with real-world experience inside regulatory organizations who understand submission pressure, authority expectations and the pace of daily operations.
Life science companies face these challenges in regulatory
Processes built for simpler portfolios that need modernization
Many regulatory processes were designed years ago when portfolios were smaller and markets fewer. The underlying logic remains sound, but growing complexity requires more structure, automation and cross-functional alignment. Without modernization, teams spend unnecessary time coordinating manually instead of moving submissions forward efficiently.
Systems that don't fully reflect regulatory workflows
RIM and regulatory systems underperform when RA requirements are not central during design and implementation. Data structures, workflows and roles often reflect earlier design choices rather than today’s regulatory reality. Ensuring RA has meaningful input during system selection and configuration turns technology into an enabler rather than an obstacle that requires workarounds.
Product data spread across systems and teams
Regulators expect consistent, structured product data aligned with standards such as ICH, IDMP and XEVMPD. Many organizations manage information across multiple systems, affiliates and markets, which complicates updates and slows responses when authorities ask for clarification. Reliable master data governance reduces rework and strengthens submission quality.
High operational pressure with limited specialized capacity
Launches, variations and new market entries create predictable peaks that stretch even mature regulatory teams. The work requires specialized expertise and moves to tight timelines, which means internal resources cannot always absorb additional load. This makes it harder to maintain predictable cycles, consistent quality and timely cross-regional coordination.
We solve this by
Regulatory process assessment and optimization
Identify gaps in roles, handovers and governance. Redesign regulatory workflows to reduce errors, improve collaboration and deliver submissions on time without adding unnecessary complexity.
RIM implementation and validation support
Configure and validate regulatory systems so they support real RA workflows. From data model design to end-user training, systems become practical tools for compliant and efficient daily operations.
Data standards and regulatory master data
Clean, structure and govern product data to meet ICH, IDMP, XEVMPD and authority expectations. Reliable data reduces rework, strengthens submissions and improves visibility across global markets.
Regulatory operations and submission readiness
Add experienced RA capacity during peak periods or complex initiatives. Specialists support coordination, data preparation, lifecycle alignment and readiness activities so internal teams stay focused and submission cycles remain predictable without permanent headcount increases.
Ready to strengthen your regulatory operations?
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What effective regulatory affairs looks like
Reliable submissions delivered on time
Clear processes, trustworthy data and supportive systems enable accurate submissions without last-minute fire drills.
Product data you can trust
Governed and well-maintained product information stays consistent and aligned with regulatory expectations across all regions.
Technology that enables regulatory work
Systems reflect real workflows and give teams the visibility they need to manage documents, track progress and stay compliant.
Stable compliance in everyday operations
Audit readiness becomes a natural result of strong governance and aligned teams. Compliance stays steady, not reactive.
Hear from our clients
Practical results delivered through deep life science expertise.
Why life science leaders choose Epista
Consultants with real regulatory experience
Our team has worked directly inside Regulatory Affairs functions at pharma and biotech companies. They understand submission pressure, authority expectations and what effective RA operations look like in practice.
Deep knowledge of regulatory systems and data standards
Our specialists bring hands-on experience with RIM implementations, IDMP readiness, master data governance and validation work. This ensures solutions that work for both compliance teams and IT.
Pragmatic and risk-based approach
We focus on what regulations actually require, not what frameworks recommend. When there is flexibility, we find efficient paths. When there is not, we design the simplest compliant solution.
Support across the full regulatory lifecycle
Whether you need strategy, implementation or operational support during peaks, we provide experienced RA specialists who understand the work and contribute from day one.