Our regulatory consultation services provide the strategic framework and operational support needed to navigate complex global regulatory landscapes. We partner with you to ensure efficient product approvals and ongoing compliance throughout your product's lifecycle.
Development of tailored regulatory roadmaps for product development, registration, and market launch.
Expert preparation, review, and management of regulatory submissions including MAA, NDA, and ANDA.
Ongoing support for variations, renewals, line extensions, and post-approval changes.
Support for scientific advice meetings, pre-submission meetings, and responses to regulatory queries.
Continuous monitoring of global regulatory changes and trends
Identifying and addressing missing data or compliance risks
Ensuring high-quality, compliant documentation
Adherence to strict regulatory standards and ethical guidelines
Experts in US FDA requirements for drugs, biologics, and devices.
In-depth knowledge of European Medicines Agency procedures (Centralized, DCP, MRP).
Specialized expertise in SFDA (Saudi Arabia), MOH (UAE), and other regional health authorities.
Full compliance with International Council for Harmonisation guidelines.