Cost-effective. Efficient. Collaborative.

Prothro Consulting Group provides strategic, hands-on solutions for regulatory, quality assurance, and compliance challenges along with support and expertise in clinical research and operations. We partner with you to identify the best path forward to produce the results that support the company’s direction and objectives.

Prothro Consulting Group is dedicated to meeting your needs. We are flexible, cost-effective, solutions-oriented and responsive. We recognize it is a big world and many companies have multiple locations. We are available to work virtually, remotely, and side-by-side. We can be an in-house resource or we can be an off-site consultative service. In addition to our international work, we have experience on the West Coast, East Coast, and areas in between.

Regulatory

Prothro Consulting Group helps define the strategy you need to move your product forward. With over 28 years of industry experience, we’ve worked in all major surgical specialties. Our experience is expansive, ranging from class I to class III, spanning the United States to over 60 countries, covering small to large markets, and encompassing 510(k) to PMA to technical files and dossiers. We’ve successfully negotiated with FDA, Competent Authorities, and other international regulatory agencies. We’ve worked in small venture backed, mid-size, and large multi-national companies. And we’ve established and implemented strategies—from concept to commercialization—along the way.

Our technology expertise includes:

• Cardiovascular
• Orthopedics
• Ophthalmology
• Sports Medicine and Arthroscopy
• Ear, Nose, and Throat
• General Surgery
• Wound Therapy
• Urology

Quality Assurance

Prothro Consulting Group designs, implements, and audits quality management systems and helps execute policies and procedures. We partner with you to ensure your systems are compliant, meet regulatory requirements, and support the company’s design and commercialization objectives. We’ve designed and managed quality management systems for small venture-backed companies, rapidly growing mid-size companies, and large, multi-national entities. We’ve managed quality management systems that have withstood countless audits with no warning letters or major observations. We’ve implemented global solutions to complex quality assurance issues and engineered solutions for companies moving from concept to commercialization.

Our experience is well rooted in:

• Good Manufacturing Practices
• Medical Device Regulation
• Complaint Management
• Risk Assessment and Management
• Design Control
• Verification and Validation

Compliance

Prothro Consulting Group is unique because our compliance experience goes beyond the typical regulatory agencies. Not only have we managed multiple FDA, notified body, and international regulatory agency inspections, but we’ve also ensured compliance through quality system audits. In addition, we’ve focused on compliance outside the company, extending all the way to the healthcare professional and other government agencies, such as DOJ.

Our scope includes compliant labeling and promotional practices, auditing reimbursement strategies and materials, and reviewing outside presentations and grant proposals to ensure internal and external requirements are met. We’ve also remediated and mitigated observations to ensure compliance and product supply. And, most importantly, we’ve protected and ensured the health of companies, from concept to commercialization.  

Our experience goes beyond:

• QMS Training
• UDI Implementation
• Promotional and Labeling Practices
• QMS Audits and Review
• Remediation and Mitigation of Audit Observations

Clinical Research

Prothro Consulting Group develops and implements clinical studies that lead to successful submission strategies. We negotiate with FDA to define the parameters of clinical studies and the successful attainment of study endpoints. Our holistic approach ensures the regulatory objectives can be met. Overall, we help you develop a strategy that forges the path from concept to commercialization.

Operations

Prothro Consulting Group has the proven expertise to design, implement, and validate solutions that lead to successful operations. Our experience lies in supply chain, procurement, and distribution along with manufacturing and planning. We’ve designed building spaces, clean work environments, and transferred processes between operations. We’ve also planned and executed the transition of strategic functions without down time or disruption. Internationally, we’ve planned and helped to establish sterilization services. Prothro Consulting Group delivers solutions that allow you to successfully move from concept to commercialization.

Expert Witness

Prothro Consulting Group has over 16 years of experience serving as an expert witness in legal cases ranging from patent litigation to product liability.