Comprehensive Regulatory Compliance Solutions

Navigating regulatory requirements is a critical component of both pharmacovigilance and clinical development. Our regulatory experts provide consulting services to help you stay in full compliance with health authority expectations.

We provide guidance on preparing and submitting regulatory dossiers for drug approvals, renewals, or variations in different countries. We assist with compiling the necessary documents and ensure submissions comply with specific requirements.

Our regulatory team offers strategic advice and intelligence to meet country-specific regulatory requirements, helping you maintain continuous compliance and adapt to evolving regulations.

Regulatory Compliance Consulting Overview

Our Regulatory Compliance Services

Expert regulatory consulting to ensure full compliance with health authority expectations and requirements

Local Regulatory Submissions

Guidance on preparing and submitting regulatory dossiers for drug approvals, renewals, or variations in different countries. We assist with compiling the necessary documents (e.g. CTD modules, cover letters, local forms) and ensure submissions comply with the specific requirements of each health authority in Asia-Pacific, and other target markets.

Regulatory Strategy & Intelligence

Strategic advice to meet country-specific regulatory requirements for pharmacovigilance and clinical trials. We monitor changes in global and local regulations, advisories, and guidelines keeping you informed of new compliance obligations. This proactive approach allows your organization to adapt in advance and maintain continuous compliance.

Audit and Inspection Readiness

Preparing your organization for regulatory audits and inspections (including pharmacovigilance inspections and GCP inspections). Our team conducts pre-audit assessments to identify gaps and helps implement corrective and preventive actions (CAPA).

Multi-Regional Compliance

Expertise in navigating regulatory requirements across multiple jurisdictions, ensuring your submissions meet the specific standards of each health authority while maintaining consistency in your global regulatory strategy.

CTD Module Preparation

Expert preparation of Common Technical Document (CTD) modules for regulatory submissions, ensuring all sections meet international standards and regional requirements for drug registration and approval processes.

Gap Analysis & CAPA

Comprehensive gap analysis to identify regulatory compliance deficiencies and implementation of Corrective and Preventive Action (CAPA) plans to address findings and maintain continuous compliance with regulatory standards.

Why Choose iPharmX for Regulatory Compliance?

Expert regulatory guidance with deep knowledge of global and regional requirements

Regional Expertise

Deep understanding of regulatory landscapes across Asia-Pacific and other target markets, enabling successful submissions and compliance in diverse jurisdictions.

Proactive Monitoring

Continuous monitoring of regulatory changes and updates, keeping you informed of new compliance obligations and helping you adapt to evolving requirements in advance.

Compliance Assurance

Our robust quality management systems and expert review processes ensure that all regulatory submissions and activities consistently meet the highest standards of compliance and are fully audit-ready

Key Benefits of Our Regulatory Compliance Consulting

Ensuring successful regulatory submissions and maintaining continuous compliance

Successful Regulatory Submissions

Our expertise in preparing and submitting regulatory dossiers increases approval success rates and reduces regulatory review timelines through compliant, high-quality submissions.

Risk Mitigation

Proactive compliance monitoring and gap analysis help identify and address potential regulatory risks before they impact your business operations or product approvals.

Audit Readiness

Comprehensive audit preparation and inspection support ensure your organization is always ready for regulatory inspections and maintains compliance standards.

Strategic Advantage

Access to regulatory intelligence and strategic guidance provides competitive advantage through better understanding of regulatory pathways and market access strategies.

Ready to Strengthen Your Regulatory Compliance?

Contact us to discuss how our regulatory compliance expertise can help you navigate complex regulatory requirements and maintain full compliance with health authority expectations.

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