Regulatory & Compliance
Ensuring global regulatory compliance through expert guidance and comprehensive dossier submissions.
Dedicated Regulatory Affairs Department
Arbro maintains a dedicated regulatory affairs department responsible for the registration of products in various countries. Our regulatory experts are involved throughout the entire project cycle, maintaining compliance with applicable laws and regulatory requirements.
We have successfully submitted numerous dossiers for regulatory and semi-regulated markets, ensuring our partners can access global markets with confidence.
Our team stays updated with ever-evolving regulatory landscapes across different geographies, providing proactive guidance to navigate complex compliance requirements.
Product Registration
Comprehensive dossier preparation and submission for product registration across multiple countries and regulatory frameworks.
Regulatory Strategy
Expert regulatory strategy development aligned with target market requirements, timelines, and compliance obligations.
Compliance Monitoring
Ongoing regulatory compliance monitoring throughout the product lifecycle, from development through post-market surveillance.
Dossier Submissions
Successfully submitted numerous dossiers for regulated and semi-regulated markets worldwide, enabling global market access for our partners.
Our Regulatory Capabilities
CTD/eCTD Dossiers
Common Technical Document preparation in electronic format for global regulatory submissions.
GMP Compliance
Manufacturing facilities compliant with WHO-GMP and Schedule M standards for pharmaceutical production.
Quality Audits
Regular internal and external quality audits ensuring adherence to national and international regulatory standards.
Need Regulatory Support?
Our regulatory affairs team can guide you through product registration and compliance requirements for any market.