Regulatory Affairs Services

Wakefield Clinical Research provides regulatory strategy and submission support for biotechnology, pharmaceutical, medical device, and IVD companies developing products in the United States.

Our team works closely with sponsors to navigate regulatory requirements, prepare high-quality submissions, and support communications with regulatory authorities throughout clinical development.

Pharmaceutical Regulatory Services
• U.S. regulatory strategy and development planning
• Regulatory gap analysis
• IND preparation and submission support
• Regulatory document preparation and review
• FDA meeting preparation and support
• Regulatory agency communications
• Protocol and informed consent review
• Regulatory project management
• U.S. Agent representation for international sponsors

Medical Device & IVD Regulatory Services
Wakefield supports medical device and IVD sponsors with U.S. regulatory strategy and submissions, including:
• Regulatory strategy and pathway assessment
• 510(k) Premarket Notification
• De Novo requests
• Investigational Device Exemption (IDE)
• Premarket Approval (PMA)
• CLIA Waiver support
• FDA meeting and communication support
• U.S. Agent representation

U.S. Regulatory Support for Global Sponsors
Wakefield provides U.S.-based regulatory support for international biotechnology, pharmaceutical, medical device, and IVD companies seeking to enter or expand clinical development in the United States. Our team can work as an extension of the sponsor's internal regulatory team or provide targeted support for specific regulatory activities and submissions.

Planning a U.S. clinical development program? Contact Wakefield Clinical Research to discuss your regulatory needs.