Experienced cGMP Consulting
Your Trusted Partner for CGMP Manufacturing Excellence, FDA Submissions, and Regulatory Advisory
What We Do
About us
The Technical Stuff
The Technical Stuff
At STIRO Manufacturing Consulting, we are dedicated to empowering pharmaceutical, biotech, and medical device companies to attain manufacturing excellence while expertly navigating the intricate regulatory landscape. With decades of experience, our team of professionals is committed to guiding you through the complexities of Current Good
At STIRO Manufacturing Consulting, we are dedicated to empowering pharmaceutical, biotech, and medical device companies to attain manufacturing excellence while expertly navigating the intricate regulatory landscape. With decades of experience, our team of professionals is committed to guiding you through the complexities of Current Good Manufacturing Practices (CGMP), FDA submissions, project management, and regulatory compliance for both medical devices and biologics.
The Technical Stuff
The Technical Stuff
The Technical Stuff
STIRO Manufacturing Consulting is proud to have a highly skilled and diverse technical staff. Our team comprises experts with a wealth of experience in various facets of manufacturing, regulatory compliance, and project management. From seasoned CGMP specialists to regulatory experts with an in-depth knowledge of FDA requirements, our st
STIRO Manufacturing Consulting is proud to have a highly skilled and diverse technical staff. Our team comprises experts with a wealth of experience in various facets of manufacturing, regulatory compliance, and project management. From seasoned CGMP specialists to regulatory experts with an in-depth knowledge of FDA requirements, our staff is well-equipped to tackle the most complex challenges. We are committed to staying at the forefront of industry advancements, ensuring that our clients benefit from the latest best practices and innovative solutions. At STIRO, our technical staff is not just knowledgeable; they are dedicated to delivering excellence and forging a path towards manufacturing success for our clients.
Our Expertise
The Technical Stuff
Our Expertise
CGMP Consulting: Our seasoned consultants understand CGMP regulations and best practices, offering assessments and solutions to optimize your manufacturing.
FDA Submissions: We have a track record of success in preparing NDAs, BLAs, and 510(k) submissions, guiding you through the FDA process.
Project Management: Our experts use industry-lea
CGMP Consulting: Our seasoned consultants understand CGMP regulations and best practices, offering assessments and solutions to optimize your manufacturing.
FDA Submissions: We have a track record of success in preparing NDAs, BLAs, and 510(k) submissions, guiding you through the FDA process.
Project Management: Our experts use industry-leading methodologies to ensure efficient project management, from planning to execution.
Regulatory Advisory: We provide tailored guidance for medical devices and biologics, helping you navigate complex healthcare regulations.
STIRO
Our Experience
After 10 years in the industry, we decided to alter direction. Now, we share our passion by helping others. Our ramp up process is designed to empower your team and outfit them with the tools they need to succeed. Talk to us today about how we can support your growth, limit your turnover, and put you on a solid track to success and profit.
Our Approach
Our service includes a comprehensive consult to help identify gaps and opportunities, a comprehensive report that includes a project plan with timelines and milestones, a cost analysis, and a schedule.
Why Us?
We offer processes and systems· GMP and regulatory training· Assistance with the registration process· Tools to design and complete IQ, OQ, PQ. That’s how we ensure your success. We provide consulting services focused on continuous improvement of manufacturing processes. STIRO offers onsite cGMP consultants to design and implement GMP-compliant