Regulatory Affairs Services
Strategy and execution support from gap analysis to lifecycle management aligned with your market and timeline.
Inspire Pharma Consultancy provides comprehensive Regulatory Affairs support across the full product lifecycle, helping companies achieve regulatory compliance, minimise risks, and accelerate market access in Saudi Arabia, the GCC, Levant, and the wider MENA region.
What We Support You
Due Diligence & Regulatory Gap Analysis
Due diligence and regulatory gap analysis help companies identify compliance risks and assess regulatory readiness before critical decisions such as product registration, licensing, or market entry. Inspire Pharma Consultancy provides structured, risk-based assessments that highlight gaps, risks, and actionable recommendations to support informed decision-making and successful regulatory outcomes.
A well-defined regulatory strategy is critical to achieving successful product approval and sustainable market access. Without a clear strategy, companies risk delays, rework, and inconsistent regulatory decision-making across markets.
Regulatory Strategy Development
Inspire Pharma Consultancy develops tailored regulatory strategies aligned with product characteristics, business objectives, and applicable regulatory requirements. Our strategic approach helps companies plan efficient approval pathways, manage regulatory risks, and achieve timely market access.
A well-defined regulatory strategy is critical to achieving successful product approval and sustainable market access. Without a clear strategy, companies risk delays, rework, and inconsistent regulatory decision-making across markets.
Inspire Pharma Consultancy supports companies in developing product-specific regulatory strategies that align with corporate goals, product profiles, and regulatory authority expectations. Our approach integrates regulatory intelligence, risk assessment, and cross-functional input to define the most efficient and compliant pathway for product development, registration, and lifecycle management.
Life Cycle Management (LCM)
Inspire Pharma Consultancy supports companies in managing post-approval regulatory activities to ensure continuous compliance and uninterrupted product availability throughout the product lifecycle. Our structured approach helps companies implement changes efficiently while aligning with regulatory authority expectations
Effective Life Cycle Management (LCM) is essential to maintain regulatory compliance, protect product supply, and support long-term commercial success. Post-strategically-can lead to regulatory delays, supply disruptions, or compliance risks.
Inspire Pharma Consultancy provides end-to-end LCM support, managing all post-approval regulatory activities in a structured and proactive manner. We treat each change as a controlled regulatory project, aligning submissions with company priorities, portfolio strategy, and applicable regulatory requirements.
Dossier Publishing (eCTD)
Inspire Pharma Consultancy provides professional eCTD publishing services to ensure regulatory submissions are accurately compiled, technically compliant, and ready for seamless review by regulatory authorities.
High-Quality dossier publishing is critical to the success the regulatory submission. Technical errors, formatting issues, or non-compliance with eCTD standards can results in validation failures, review delays, and additional requlatory questions.
Inspire Pharma Consultancy offers end-to-end eCTD publishing services, supporting original applications, variations, renewals, and responses to regulatory authority queries. Our experienced team ensures dossiers are structured, formatted, validated, and submitted in full compliance with eCTD technical requirements and authority-specific guidelines.
Labeling Compliance
Inspire Pharma Consultancy supports companies in developing and maintaining accurate, compliant, and market-ready product labeling in line with regulatory and pharmacovigilance requirements.
Inspire Pharma Consultancy provides comprehensive labeling compliance support, covering both pre-approval and post-approval activities. We assist companies in preparing, reviewing, and managing labeling materials such as outer and inner packaging, leaflets, SmPCs, and IFUs, ensuring alignment with current regulatory approvals and safety data.
Need a Regulatory Roadmap?
Share your product stage and target market, and we’ll recommend the right approach.