Quality Assurance and Regulatory Affairs
Global Regulatory Submissions & Compliance
Your Preferred Partner in Global Regulatory Strategy
Expanding into global markets requires a deep understanding of regional regulatory frameworks and submission requirements. Our global regulatory consulting services help MedTech manufacturers seamlessly navigate the complexities of worldwide compliance, ensuring faster approvals and smooth market entry.
With a proven record of supporting leading medical device companies, we simplify the process of obtaining approvals across regions such as the United States, Europe, India, the UK, Japan, Australia, South Korea, Brazil, and beyond. Our team of global regulatory professionals provides the knowledge and strategic insight needed to guide products through the most demanding review processes.
Our experts craft region-specific regulatory strategies to align with both, local and international requirements. This helps you to accelerate approval timelines and achieve successful market access.
Comprehensive Global Regulatory Submissions Services
Regulatory strategy development and pathway optimization based on product classification, risk profile, and target markets
Pre-submission strategic services including health authority interactions, FDA Q-Submissions, and regulatory intelligence
Query and deficiency response support with authority liaison and meeting management
In-country representative services and import/export licensing facilitation
Country-specific registration and renewals with dossier support for:
- US FDA: 510(k), De Novo, PMA, IDE, 513(g), Breakthrough Device Designation, Emergency Use Authorization
- EU/UK: MDR/IVDR Technical Documentation, CE Marking, UKCA.
- Major Markets: CDSCO (India), MHRA (UK), TGA (Australia), PMDA (Japan), MFDS (Korea), ANVISA (Brazil), COFEPRIS (Mexico), NMPA (China), and 150+ additional markets