About Us
Transform Compliance into Your Competitive Edge
About Us
Bottom Line Results Consulting LLC is more than just a consulting firm; we are your strategic partner in the complex medical device and biotechnology regulation. Founded by industry veteran Ghazi Kashmolah, our company is built on deep regulatory experience, a commitment to quality, and a passion for seeing your innovations thrive in the marketplace.
Our Vision
At Bottom Line, we envision a world where compliance is not a roadblock or a burden but a stepping stone to more incredible innovation and market success. We aim to be the catalyst that transforms regulatory challenges into competitive advantages for our clients.
Our Mission
Our mission is to deliver unparalleled regulatory and quality consulting services that empower medical device and biotechnology companies to navigate global markets confidently. We strive to:
- Ensure Compliance: From FDA submissions to international regulatory landscapes, we guide you through with precision and foresight.
- Enhance Quality: Through strategic QMS optimization, we help you achieve and exceed quality standards, focusing on efficiency and cost-effectiveness.
- Drive Innovation: We ensure your innovations are market-ready by integrating cutting-edge practices like Software as a Medical Device (SaMD) compliance.
From Warning to Winning: A FDA 483 Turnaround
A leading medical device manufacturer faced a daunting FDA 483. With our strategic intervention, not only did they achieve full compliance, but they also enhanced their product’s market position.
Ghazi Kashmolah - Our Founder
With over three decades of experience, Ghazi Kashmolah has been at the forefront of quality assurance, regulatory affairs, and operational excellence in the medical device and biotech sectors. His career spans leadership roles where he has:
- Served as Chief Quality Assurance, Regulatory Affairs, and EH&S Officer at Orchid Orthopedic Solutions.
- Led global quality and regulatory affairs as Senior Vice President at DJO Global.
- Been instrumental in quality and regulatory transformations at OSI Systems, Life Technologies, and Cardinal Health, among others.
Ghazi’s expertise encompasses:
- Regulatory Strategy: Mastery in navigating FDA processes, managing warning letters, and securing global market approvals.
- Quality Systems: Pioneering approaches in QMS development, ISO certifications, and operational efficiencies.
- Risk Management: Proficient in risk assessment and remediation, ensuring products from concept to post-market meet the highest standards.
Susan Qualey
Susan Qualey is a trusted expert in the analysis, development and implementation of medical device quality systems. She has experience transitioning paper-based systems into compliant electronic systems, streamlining existing electronic systems to better meet business needs, and expanding electronic systems to new business locations. She is an ISO 13485 Lead Auditor and has prepared business plans for the new FDA Quality Management System Regulation effective February 2026. Susan also holds a Regulatory Affairs Certification and is skilled in technical writing.
Testimonials
“The audit was a resounding success with absolutely no discrepancies; this flawless performance was acknowledged by the audit leader stating that this was the cleanest audit he had ever conducted in over 20 years.”
Group President
“Your quick and effective turn-around on our quality performance with our key customer saved our business from losing $25 M in revenue. Thank you!”
CEO
“The quality yield improvement we observed over the last three months had a very positive impact on our business; we thank you for getting us there”
CMO End-Customer
“The quality record system is well integrated and managed”
OEM Lead Auditor
“Your new trade compliance process resulted in 30 days improvement in processing time of our goods into the country allowing us to meet our end customers demand more effectively”
CEO/COO
“The reduction of the field failure rate on our highest deployed product line has significantly reduced our field service cost and improved customer satisfaction”
CEO/VP Global Service
“Your MDSAP audit preparation and employee training was instrumental in the company passing this critical audit with Zero findings”
CEO
“Thank you for the efficient and thorough technical files remediation efforts; this work was instrumental in avoiding major revenue interruption in our European operations”
CEO, EU Division President
“We appreciate the timely and successful warning letter remediation”
CEO/CFO
Unparalleled Expertise, Proven Results
Decades of Experience
Our team has navigated the most complex regulatory environments.
Tailored Strategies
Our team has navigated the most complex regulatory environments.
Client-Centric Approach
Your success is our success. We're committed to your growth at every step.
Global Reach
With insights into both US and international markets, we ensure your products are compliant worldwide.
Join Us in Shaping the Future
At Bottom Line Results Consulting LLC, we’re not just about compliance but excellence, innovation, and results. Whether you’re tackling an FDA inspection, aiming for ISO certification, or seeking to innovate with SaMD, we’re here to ensure your vision becomes reality. Let’s navigate the regulatory landscape and turn your compliance into your competitive edge.