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 Devices 

We support companies developing and implementing best winning CE mark strategies for fast market access in Europe.