Welcome to TedMed Engineering Projects, TMEP Consulting
With more than 18 years of experience across roles including PMP-certified Project Manager, Certified Scrum Master, SAFe practitioner, Validation Engineering, Quality Engineering, Biomedical Engineering, and Regulatory Compliance Management—spanning regulatory, R&D, and manufacturing for drugs and medical devices—TMEP Consulting was founded to bring this expertise to your projects. Together, we deliver deep industry knowledge, practical solutions, and measurable results. Contact us to schedule a consultation.
Consulting with Purpose
Projects can be demanding — we’re here to take the burden off your shoulders. Our consultant put our clients’ interests first, delivering capability, adaptability, and scalable solutions. Since 2007, we’ve served loyal clients across the US and Worldwide. Contact us to get started and experience our services firsthand.
Consulting Services
Implementation Planning
Are you a startup or growing life‑sciences company with a breakthrough drug or device? TMEP provides end‑to‑end Regulatory Project Management and Engineering services, PMOA strategy, IND/IDE planning, CMC/DHF alignment, quality systems, and global market entry so you can focus on innovation while we deliver regulatory success.
• Full lifecycle support: discovery → nonclinical → clinical → commercialization.
• Integrated drug + device expertise: regulatory strategy based on PMOA and combined submissions.
• CMC & DHF alignment: unified documentation, traceability matrices, and change-control coordination.
• Clinical & nonclinical planning: IND/IDE readiness, human factors, stability, and bench testing.
• Global market entry: regulatory pathway selection, submissions, and post‑market compliance.
• Strategy & FDA Engagement: PMOA determination, OCP engagement, pre‑IND/IDE briefing packages, and submission support.
• CMC & Device Engineering: aligned CMC development and DHF creation, supplier qualification, and analytical/sterility strategy.
• Nonclinical, Bench & Clinical Readiness: biocompatibility, bench verification/validation, animal models, usability testing, and clinical protocol development.
• Quality & Risk Management: cGMP and QMS implementation, ISO 13485 alignment, ISO 14971 risk management, CAPA, and complaint handling.
• Project Management & Execution: integrated Gantt/timeline, cross-functional coordination, milestone tracking, and regulator liaison.
• Post‑Market Support: surveillance plans, adverse event reporting, and change-control/regulatory submissions.
Client outcome statement (impact-focused)
Schedule a free 30‑minute PMOA assessment.
Request a tailored regulatory roadmap for your program.
Consultancy
As consultants, our clients are our top priority, and our services reflect our commitment to their success. TMEP Consulting have built a client-focused consulting model dedicated to delivering results. Book an introductory meeting today to learn more about the services we offer below.
• Project Delivery Management
• Drug & Medical Device R&D Lifecycle Management
• GLP, GCP, and GMP Compliance Systems
• Clinical Trial Management, Auditing & Monitoring
• Quality Assurance & Quality Control
• Medical Device Equipment Calibration & Qualification
• FDA Regulatory Strategy & Submissions
• Insurance Credentialing
Strategizing
Our services are tailored to each client’s unique needs. We collaborate closely at every stage, delivering measurable results and clear accountability. Contact us to learn how we can support your project and drive successful outcomes.
TedMed Engineering Projects provided exceptional medical equipment calibration services—prompt, precise, and fully compliant with regulatory standards. Their team demonstrated deep technical expertise, clear communication, and minimal downtime, enabling us to maintain high-quality patient care. We highly recommend their services."
Quinn Davis
TedMed Engineering (TMEP Consulting) delivered an outstanding IQ/OQ/PQ qualification service for our facility. Their team demonstrated strong technical knowledge and a thorough understanding of regulatory expectations. Installation Qualification was completed meticulously, Operational Qualification testing was comprehensive and clearly documented, and Performance Qualification validated equipment performance under real-world conditions. Their protocols were well-written, test execution was efficient, and the final reports were detailed, easy to follow, and audit-ready. Communication throughout the project was proactive and professional, and they provided practical recommendations to improve long-term reliability and compliance. TMEP made the entire qualification process smooth and stress-free . I highly recommend their IQ/OQ/PQ services to any organization seeking reliable, compliant validation support."
Sandy Williams
TMEP Consulting managed our regulatory submission project with exceptional professionalism and precision. From project kickoff through final submission, their team provided clear timelines, comprehensive document control, and expert guidance on regulatory strategy. They coordinated cross-functional contributors, ensured dossier completeness, and produced well-organized submission packages that met regulatory authority expectations. When questions arose, TMEP responded promptly with well-reasoned, audit-ready responses and helped prioritize remediation actions to keep the project on schedule. Their proactive risk management, attention to detail, and strong stakeholder communication significantly reduced our regulatory burden and improved submission quality. We achieved a smooth review process and greater confidence in our regulatory readiness—highly recommended for any organization seeking expert submission project management."
Casey Johnson
