Having worked for large companies over the years, I was used to a well-established company identity. Sure, there might be tweaks to mission statements or operating strategies, but core aspects like being a manufacturer were set in stone.

However, recent conversations have shown me that this isn't always the case for startups. After spending years focused on research, the shift to manufacturing can bring unexpected challenges. One key area is FDA Good Manufacturing Practices, which include process validation. These are new hurdles for a startup that's ready to grow into a manufacturing facility.

While these concerns may not be as dramatic as others, they are just as crucial for the long-term health of the business. Meeting regulatory expectations is a must for any manufacturer.

Don't let compliance be your stumbling block. Contact Brayearst Validation Consulting today and let us guide you through the maze of FDA rules, ensuring your startup's long-term success.