TEDMED Engineering Projects (TMEP Consulting)
About Us
At TedMed Engineering Project Consulting, we specialize in delivering expert project management and regulatory consulting services across the full spectrum of drug and medical device research and development. Our mission is to help life science organizations navigate the complex journey from concept to commercialization with precision, compliance, and confidence.
With over 18 years of industry experience, we bring deep expertise in regulatory affairs, validation, quality systems, and product development. Our team of PMP®-certified Project Managers and Certified Scrum Masters integrates traditional and agile methodologies to ensure efficient execution, risk mitigation, and successful project delivery — on time and in full compliance with global regulatory standards.
We partner with pharmaceutical, biotechnology, and medical device companies to provide strategic oversight, regulatory alignment, and technical leadership throughout each phase of the product lifecycle. From pre-clinical research and process validation to clinical trials and market approval, we ensure that every project meets the highest standards of quality, safety, and regulatory integrity.
At TedMed, we don’t just manage projects — we build partnerships that accelerate innovation and advance global health. Our commitment to excellence, transparency, and scientific rigor drives every engagement, helping our clients bring transformative therapies and technologies to the patients who need them most.
. Our founder, saw the need to create a consulting firm that can support sponsors, and other stakeholders translate medical device ideas from the lab, and bench into commercial devices and to also assist scientist bring their drugs from preclinical, animal testing, human testing phases; all the way to commercial manufacturing. We provide services to assist with the design, conduct, performance, monitoring, auditing, recording, analyzing and reporting of clinical research to ensure that regulatory guidelines for the safety of the human subject are followed.
We are contract, consulting and project to project clinical research and engineering firm. We provide clinical trial management and regulatory services. We work with Pharmaceutical, Biotechnology, Hospitals, Clinics, Research sites, CDMO, CMO, CRAMS, CRO and Medical Device companies.
We provide our clients the option to obtain our services on either project-by-project basis, contract, or consultants for the duration of the project.
We have developed and gained approval on numerous Class I, II, and III devices. We also own clinical research sites, and we perform phase II to IV study working with Sponsors, CRO's and investigator-sponsors.
Our clients return to us because we strive to exceed expectations. We are dedicated to bringing new medical products to market that are safe and effective for patients. We utilize our years of engineering, regulatory, and clinical expertise to support sponsors, who need help moving their product from concept to commercialization.
We support entrepreneurs, developers, and manufacturers of medical products through the entire product life cycle; providing services as needed from initial concept through product approval to post market needs.
We are also biotechnology engineers, we fix, perform preventive maintenance, validate, commission and qualify medical devices.
Mission
Mission Statement : To empower life science organizations to bring safe, effective, and innovative medical products to market through strategic project management, regulatory expertise, and a commitment to quality and compliance excellence. We partner with clients to streamline development, reduce risk, and ensure every project meets global regulatory standards — from concept to commercialization. We help advance healthcare innovation by providing expert project management consulting services that drive excellence in drug and medical device research and development. We partner with clients to streamline complex regulatory pathways, ensure compliance, optimize quality systems, and deliver safe, effective, and innovative products to patients faster.
Vision
Our vision is to strive to exceed expectations by understanding our customers needs, requirements and expectations. We can only successfully exceed stakeholders expectation, when we listen and understand their needs and work to provide it.
It's our vision to keep stakeholders engaged and informed, so we can provide 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.
Our Focal Point of Excellence
Our free training and education are focused on creating skillful research professionals, who utilizes advanced industry best practices to provide excellent service.
We are a devoted team of subject matter experts, whose combined intelligence is another means for TMEP customers to tap into our rich resources and years of collective experience in the industry.
Who we are
We project managed a team of Biomedical Engineers, Biomedical Coordinators, Clinical Research Associates, Biomedical Managers, Project Coordinators, Project Managers, Clinical Research Project Managers, Validation Managers, Data Managers, Clinical Research Regulatory Directors among other industry titles.
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When you hire us, you get experienced professionals. We are knowledgeable and educated consultants with associates, bachelors and graduate education in Biomedical Engineering, Engineering management, Project Management, Clinical Research, and Regulatory Affairs. We have consultants and contractors who have ICH GCP training from ACRP, SOCRA, NIDA, and CITI and also GLP and GMP training.
We have a team of experienced Quality and Regulatory Managers with an extensive knowledge of FDA, EMA, DEA, ISO, IRB standards and regulations etc.
We continue to learn and train, to accommodate industry changes to better assist our clients.
TMEP is not just a Therapeutic Clinical Research Management firm, we are also a Medical Device Research and Engineering firm. We assist start up sponsors with the entire lifecycle of a Medical Device and Drug Research and Development. We work with FDA to classify your new device, assist with all other submissions and clinical research study.
Our regulatory knowledge and experience make us an asset to sponsors looking to speed up the submission process to product marketing. From device classification, 513g submission, IDE application, PMA etc.
We work directly with FDA on your behalf. We pride ourselves as experienced Clinical Research Professional among many other industry job titles. We are dedicated to the success of your most complicated research projects. We serve as SME.
medical EQUIPMENT SERVICE MANAGMENT
