Welcome to Bellingswood Regulatory Consulting
We provide leadership for strategy and regulatory consulting at the highest level.
• Global Strategy Development
• Process Optimization
• FDA & CE Mark Submission
• Clinical Evaluation MEDDEV 2.7.1 Rev.4
• Usability & Human Factor
• FDA Mock Audits
• GMP and ISO Audits
• Supplier Audits
Bellingswood Consulting partners with clients in the medical device and pharmacy industry to identify their highest-value opportunities and address their most critical challenges to overcome the burden of the highly regulated environment.
Global Regulatory Strategy
We support companies around the world developing and implementing best winning strategies in the area of medical devices and pharmacy.
• We lead you interpreting current and future regulations.
• We show you the best winning regulatory strategies and provide you help to overcome the regulatory burden with authorities.
Quality Management Excellence
We lead companies around the world analyzing and improving their process landscape. We help developing and implementing best strategies to beat the market.
• Quality Management System
• Change Management Process
• R&D Control and Process Management
• Customer Complaint and CAPA System
• Vigilance System
• Purchasing Management System
• Communication and Crisis Management
Audits & FDA Inspections
We help companies to identify gaps and flaws in their quality management system. We perform internal audits with many years practical experience leading our clients to meet all regulations and regulatory requirements. We support companies to meet GMP compliance and to get best preparation in order to pass an FDA inspection with flying colors. We provide internal GMP training and prepare you for your next FDA inspection
FDA Registration Medical Devices
We support companies developing and implementing best winning FDA strategies.
510(k) - Premarket Notification
We show you how to prepare the most effective 510(k) for a fast and successful FDA market clearance.
PMA - Premarket Application
We show you how to prepare the most effective PMA for a fast and successful FDA market clearance.
CE Mark Registration Medical DevicesWe support companies developing and implementing best winning CE mark strategies for fast market access in Europe.