Services
Transform Compliance into Your Competitive Edge
Our Services
At Bottom Line Results Consulting LLC, we offer comprehensive services tailored to medical device and biotechnology companies’ unique needs. Our approach is strategic, proactive, and deeply rooted in decades of industry experience. Here’s how we can support your journey:
Quality & Regulatory Consulting Projects:
- Gap assessment (people, process, tools)
- Staff augmentation, up to and including fractional CxO
- M&A due dilligence support
- Organizational design effectiveness
Regulatory Strategy
- FDA Compliance Consulting: From navigating 510(k), De Novo, and PMA submissions to ensuring 1st attempt success. Our experts guide you through FDA processes with precision.
- Global Product Registration & Commercialization: We specialize in securing approvals across global markets, including EU MDR, Asia-Pacific, and beyond, ensuring your product’s worldwide compliance with local and global regulations.
- FDA Remediation Services: Our expertise in managing FDA 483s, warning letters, and consent decrees turns regulatory challenges into opportunities.
- FDA Audit Readiness
- Recall Management Support
Quality Management Systems (QMS)
- QMS & Organization Optimization: Design, implement, or enhance your QMS to meet ISO 13485, ISO 9001, AS 9100, and MDSAP standards. Our focus is on reducing costs while improving quality and efficiency.
- CAPA and Complaint Handling: Develop robust systems for corrective and preventive actions, ensuring compliance and improving product quality.
- Internal & Supplier Audits: Prepare for and conduct internal and external audits with our team, ensuring your company is always FDA audit-ready.
Productivity, Efficiency & Cost Reduction
- Reduce inspection cost through process optimization
- Simplify complex processes via Lean mapping
- Streamline policies and procedures
- Reduce cost of scrap and rework by addressing root cause
- Safe work environment assessment and mitigation
Optimize & Safeguard Your Global Supply Chain
- Assess Current and Future Tariff and Non-Tariff Barriers
- Standard Import Duty and Tax
- Punitive Import Duty and Tax
- Other Import Restrictions and Limitations
- Mitigate Current and Future Supply Chain Disruptions
- Foreign Supplier Documentation Errors and Omissions
- Inaccurate Product Marketing and Labeling
- Other Supply Chain Partner Errors and Omissions
- Minimize Unnecessary Cash Flow Leaks
- Maximize Import Duty and Tax Minimization Strategies
- Leverage Free Trade Agreements (FTAs)
- Foreign Trade Zones and Bonded Warehouse Operations
- Implement Audit-Readiness Framework and Controls
- Assess Current Control Areas
- Push Regulatory Controls Upstream
- Establish Key Performance Indicators (KPIs)
Staff Augmentation
- Regulatory & Quality Staff Augmentation: Need expert help but not full-time? Our staff augmentation services provide the right expertise upto an including fractional leadership when you need it, from strategy development to tactical executions.
- Training and Development: Equip your team with the latest knowledge through customized training programs on regulatory, quality, and industry best practices.
Our 7-Step Engagemet Process
- Initial FREE consultation with client to understand needs
- Sign NDA and submit SOW for client approval
- Perform gap assessment
- Establish remediation or project plan
- Review gaps and plan with client for go-forward approval
- Deploy resources and begin execution
- Deliver results, complete project and transition
Transform Your Regulatory Challenges into Success?
Each service is designed with your company’s success in mind. Whether you’re launching a new product, expanding globally, or facing a regulatory challenge, we’re here to help.