Regulatory & Compliance Advisory Services
Relyaint provides structured, inspection-ready advisory services designed for regulated pharmaceutical, biotech, and medical device environments.
Regulatory GAP Assessments
Inspection-ready GAP assessments across GxP, CSV, and data integrity domains.
Validation & CSV Advisory
Risk-based validation and computerized systems assurance aligned with regulatory expectations.
Data Integrity Assurance
Assessment and remediation advisory focused on ALCOA+ and governance controls.
Compliance Readiness Programs
Structured preparation for inspections, audits, and regulatory engagements.
Regulatory GAP Assessments
Provides an objective, comprehensive view of your current compliance posture against global regulatory mandates, identifying the critical “short-term” fixes needed for immediate safety and “long-term” structural changes for lasting compliance.
What We Do
Regulatory Requirement Mapping: Aligning your operations with specific FDA, EMA, and ISO standards.
Evidence-Based Control Review: Verifying that internal safeguards are functionally effective under audit conditions.
Risk-Prioritised GAP Identification: Pinpointing deficiencies and quantifying their potential impact on your business continuity.
Inspection-Defensible Reporting: Creating a transparent audit trail that justifies every finding to external regulators.
What You Receive
Structured GAP Register: A centralized database of all identified compliance disconnects.
Risk-Classified Findings: Categorization of issues by severity to guide budget and resource allocation.
Advisory Remediation Guidance: Expert strategies for both rapid “patch” fixes and sustainable system overhauls.
Executive-Ready Report: High-level summaries for leadership supported by granular, actionable technical data.
All regulatory applicability and GAP determinations are confirmed by qualified human reviewers.
Validation & CSV Advisory
Identifies critical failures in system lifecycle management and “technical debt” in legacy software. We bridge the gap between out-of-date validation packages and current GxP/Part 11 requirements, ensuring your digital infrastructure is both compliant and performant.
What We Do
Lifecycle GAP Analysis: Evaluating the delta between your existing system documentation and the full GxP lifecycle requirements.
Risk-Based Validation (RBV) Calibration: Shifting from “blanket testing” to high-impact verification that targets your specific system vulnerabilities.
Legacy System “Hardening”: Identifying short-term compensatory controls for aging systems that cannot be immediately replaced.
CSA (Computer Software Assurance) Transition: Moving your firm from burdensome, paper-heavy CSV to modern, streamlined assurance models.
What You Receive
Validation Maturity Assessment: A granular report card on your current software quality and compliance health.
Short-Term Remediation (Tactical): Immediate “hot-fixes,” such as missing SOPs, interim access controls, or supplemental testing for critical functions.
Long-Term Remediation (Strategic): A multi-year roadmap for system upgrades, cloud migrations, or full lifecycle automation to ensure permanent compliance.
Audit-Defensible Traceability Matrix: A verified map linking requirements to risks and tests, designed to satisfy a technical inspector’s scrutiny.
All regulatory applicability and GAP determinations are confirmed by qualified human reviewers.
Data Integrity Assurance
Identifies vulnerabilities in the generation, transformation, and storage of GxP data. We uncover hidden risks in your data lifecycle that lead to “Warning Letters” and provide the remediation steps to move your culture from reactive checking to proactive integrity.
What We Do
Lifecycle Vulnerability Mapping: Identifying “Gaps” in the data flow where information is at risk of being unrecorded, modified, or deleted without attribution.
ALCOA+ Alignment Audit: Evaluating every process against the standards of being Attributable, Legible, Contemporaneous, Original, and Accurate.
Technical & Behavioral Assessment: Analyzing both the system settings (Audit Trails) and the human pressures (Workload/Culture) that lead to integrity failures.
Legacy Data Remediation: Developing “Short-Term” compensatory controls for systems that lack native audit trails or secure logins.
What You Receive
Structured GAP Register: A centralized database of all identified compliance disconnects.
Risk-Classified Findings: Categorization of issues by severity to guide budget and resource allocation.
Advisory Remediation Guidance: Expert strategies for both rapid “patch” fixes and sustainable system overhauls.
Executive-Ready Report: High-level summaries for leadership supported by granular, actionable technical data.
All regulatory applicability and GAP determinations are confirmed by qualified human reviewers.
Compliance Readiness Programs
Removes the regulatory barriers to entry for companies breaking into new global markets. We identify the “delta” between your current domestic operations and the specific expectations of target bodies (FDA, EMA, MHRA, TGA etc.), providing a dual-layered remediation strategy to ensure first-time approval.
What We Do
Cross-Market Regulatory Mapping: A side-by-side GAP analysis of your current quality system versus the specific mandates of the target regulatory body.
New Market “Pressure Testing”: Simulating the unique inspection style of the new jurisdiction (e.g., shifting from FDA “Systems-Based” to EMA “Product-Focused” inspections).
Technical Dossier Review: Identifying gaps in your existing validation and data integrity evidence that may not meet the higher or different thresholds of the new market.
Cultural & Procedural Translation: Aligning your site’s “Compliance Language” and SME presentation styles with the specific cultural expectations of international inspectors.
What You Receive
Market Entry Risk Roadmap: A prioritized list of “Showstoppers” that must be remediated before filing or announcing an inspection date.
Short-Term Remediation (Tactical): Rapid “Bridge” SOPs, supplemental validation protocols, and interim governance measures to meet the new market’s immediate entry requirements.
Long-Term Remediation (Strategic): A harmonization plan to unify your global quality management system (QMS), reducing the cost of future expansions.
The “Approval-Ready” Playbook: A market-specific guide for SMEs and leadership on how to defend existing processes to a new type of regulator.
All regulatory applicability and GAP determinations are confirmed by qualified human reviewers.
Initial Advisory Discussion | Submission of Documents
Scope Definition & Regulatory Context
Structured Assessment & Advisory Execution
Executive & Inspector-Ready Deliverables
Engagements are advisory in nature and tailored to organizational context and regulatory scope.
Discuss Your Compliance Priorities
Engage with our advisory team to evaluate your current regulatory challenges and determine the most effective path forward.
No obligation. Confidential discussion.