Strategic Support for FDA-Regulated Medical Devices and Pharmaceuticals
Entering and operating in regulated markets requires more than compliance. It requires a clear regulatory strategy, well-structured documentation, and alignment between product development, quality systems, and regulatory expectations.
Medical Devices and Pharma (MDP) provides practical, experience-driven regulatory and quality system support across the full product lifecycle. We work with manufacturers, developers, and regulatory teams to navigate U.S. and global requirements efficiently and with confidence.
How We Support You
Our services are structured around the key regulatory functions required for successful market entry and ongoing compliance.
U.S. Market Entry and FDA Pathways
We support manufacturers in selecting and executing the appropriate regulatory pathway for entry into the United States. Read more about the pathways for 510(k) premarket notification, premarket approval (PMA), and De Novo requests.
Explore U.S. market medical device entry pathways
U.S. Agent and Regulatory Presence
For non-U.S. manufacturers, we provide U.S.-based regulatory representation and communication support required for FDA registration and compliance. This includes U.S. Agent services, Official Correspondent support, FDA communication management, and market entry guidance.
Learn About U.S. Agent and Market Entry Support
Quality Management Systems (QMSR & ISO 13485)
We help organizations align their quality systems with evolving regulatory expectations, including FDA’s transition to the Quality Management System Regulation (QMSR). QMS audits and gap assessments, QSR to QMSR transition support, ISO 13485 alignment, CAPA system assessment, and compliance remediation.
Explore QMSR Transition and Quality Services
Regulatory Strategy and Submissions
We develop and execute regulatory strategies that support efficient product development and successful submissions. Strategies include regulatory pathway strategy, submission planning and execution, global market expansion, and reimbursement considerations.
Regulatory Writing and Documentation
High-quality regulatory documentation is critical to successful submissions and agency interactions.
We support the preparation of 510(k), PMA, and De Novo submissions, regulatory correspondence, technical reports and summaries, and structured, compliant documentation.
FDA Interaction and Meetings
Effective communication with the FDA is essential to reducing uncertainty and avoiding delays. We support pre-submission (Q-Sub) strategy and preparation, FDA meeting coordination and facilitation, and documentation of regulatory interactions.
Compliance, Recalls, and Enforcement Support
When regulatory issues arise, timely and appropriate response is critical. We assist with FDA Warning Letter response, recalls and field actions, compliance remediation strategies, and crisis and escalation management.
Why Work With MDP
We combine regulatory expertise with practical execution. Experience in high-risk and life-sustaining technologies. Deep understanding of FDA expectations and quality systems. Independent, objective regulatory perspective. And clear, defensible communication.
Get Started
Whether you are planning a new product, preparing a submission, or addressing a compliance issue, we can help you define a clear path forward.
