About Us
TedMed Engineering & Projects (TMEP Consulting) is a women‑owned, minority, small business and employee‑owned consultancy delivering customized engineering- equipment calibration & repair, validation, regulatory, and clinical project services. We engage a vetted network of independent consultants to provide flexible access to specialized expertise while maintaining rigorous quality, accountability, and client confidentiality.
Experience and Expertise:
• Over 18 years of industry experience across pharmaceuticals, biotechnology, and medical devices.
• Deep subject‑matter expertise in regulatory affairs, validation, quality systems, product development, and clinical research.
• PMP®â€‘certified Project Managers and Certified Scrum Masters who integrate traditional and agile methodologies to deliver projects on time, on budget, and in compliance with global regulatory standards.
Core Services
• Regulatory Strategy & Submission Support (drug and device): regulatory planning, dossier preparation, submission project management, and interactions with regulators.
• Validation & Qualification: IQ/OQ/PQ, equipment commissioning, calibration, preventive maintenance, and validation documentation.
• Clinical Research & Trial Management: design, conduct, monitoring, auditing, data recording, analysis, and reporting for Phase II–IV studies; clinical site operations and sponsor/CRO partnerships.
• Quality Systems & Compliance: quality system design, audits, CAPA support, and readiness for inspections.
• Engineering & Product Development: product design translation from lab/bench to commercial device, prototypes, risk management, and manufacturing support.
• Project & Program Management: integrated project leadership, vendor coordination, risk mitigation, and cross‑functional stakeholder communication.
Client Types:
We serve pharmaceutical companies, biotechnology firms, medical device manufacturers, CDMOs/CMOs, CROs/CRAMS, hospitals, clinics, research sites, Lab, sponsors, and entrepreneurs.
Notable Capabilities:
• Experience obtaining approvals for numerous Class I, II, and III medical devices.
• Operation of clinical research sites and direct experience executing multi‑phase clinical trials.
• Flexible engagement models: project‑by‑project, fixed‑term contracts, Corp‑to‑Corp (C2C), or individual 1099 consulting arrangements—allowing clients to choose the procurement and liability posture that best fits their needs.
Why Clients Return :
Clients choose TMEP for our proven technical expertise, collaborative approach, and commitment to measurable results. We focus on delivering audit‑ready documentation, practical regulatory and engineering solutions, and program leadership that reduces time to market while maintaining patient safety and regulatory integrity.
Founder’s Vision:
Our founder established TMEP to bridge the gap between scientific innovation and commercialization—supporting sponsors and stakeholders in turning medical device and drug ideas into safe, effective products for patients.
Mission Statement
TMEP Consulting partners with clients to manage project deliverables and ensure successful outcomes delivering safe, compliant, and effective product development and manufacturing solutions. We partner with organizations to manage project deliverables from concept to commercialization, ensuring timely outcomes through expert regulatory, engineering, and quality guidance.
We support clients across product development, equipment commissioning, and manufacturing with services that include: Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Equipment Installation, IQ/OQ/PQ and IPV qualification, preventive maintenance programs, regulatory submission strategy and support, Quality Management System (QMS) implementation and improvement, and regulatory compliance auditing.
Vision Statement
We thrive to exceed expectation. TMEP Consulting envisions a future where every engagement exceeds stakeholder expectations. We exceed expectation by actively listening, maintaining transparent communication, and staying closely aligned with client requirements. We exceed expectations by deeply understanding our clients’ needs and keeping stakeholders engaged and informed throughout every project, so we deliver exactly what they require."
Value Statement
At the core of our consulting practice is a dedication to integrity, innovation, and impact.
We deliver measurable value through:
• Quality & Compliance: Upholding the highest standards in validation, regulatory alignment, and risk management.
• Expert Leadership: Applying over 18 years of cross-functional experience in medical device and drug development project management.
• Collaboration & Transparency: Building trusted partnerships that foster accountability and continuous improvement.
• Efficiency & Excellence: Driving projects with precision, agility, and a results-oriented mindset to accelerate time-to-market.
• Regulatory Strategy & Compliance : Focusing on navigating global regulatory requirements (FDA, EMA, ISO, etc.) for drugs and medical devices.
•.Validation & Quality Engineering : Emphasizing quality systems, process validation, and compliance excellence.
• End-to-End R&D Project Management : Covering all stages from concept and feasibility to clinical trials and product launch.
• Technical & Engineering Consulting : Highlighting product design, testing, and technical problem-solving expertise.
• Combination of Regulatory, Validation, and Project Leadership : Utilizing a balanced approach showing full-spectrum expertise.
