Why Us?
Cooperative
We keep the patient or end user in mind as we render services to our clients. In doing so TW Consulting & Associates, LLC has established cooperative relationships with clients, government agencies, and stakeholders.
Innovative
As technology advances, so does opportunity to improve the lives of people beyond just our local borders. We have supported product registrations for new and modified medical devices in 50+ countries in all major markets.
Progressive
As either a start-up, mid-size, or large company we understand the needed commitment for introducing safe and effective products to the market. TW Consulting & Associates, LLC will navigate the least burdensome marketing pathway for your company.
Testimonials
”I worked along side Terrina on a complex regulatory affairs project at a large orthopedic implant medical device company. Terrina coordinated the work of regulatory affairs specialist employees and contractors located at multiple sites throughout the world to prepare the technical documentation to support pre-marketing registration. Her knowledge of worldwide regulatory requirements and team leadership skills kept the project moving smoothly and within time and resource budgets. Terrina is a true professional and a strong asset to any medical device regulatory affairs endeavor. I recommend her without reservation.”
“I recently contracted with TW Consulting and Associates to remediate some technical documentation. Terrina was a joy to work with. She is skilled at proactively recommending creative approaches that fit the needs of my project. I appreciated her timelines, thoroughness and attention to detail.”
“Terrina is an asset to any regulatory organization. She takes tremendous pride in ensuring that she provides clarity, top-notch results and strong knowledge transfer throughout her engagements. She is dependable, diligent and delivers what she promises. Most importantly, Terrina is honest and loyal to her teammates, leadership and project.”
“I had the pleasure of having Terrina as a trusted colleague during my time at Merit Medical. Terrina has a large breadth of international and domestic Regulatory knowledge, and despite the complexity of that field, she is able to maintain compliance while keeping communication and processes simple and succinct for everyone else involved. She is an outstanding mentor to not only subordinates but also managerial staff members on complex Regulatory issues. No task was too complicated for Terrina to excel. I would hire Terrina again and likewise strongly consider working directly for her if the opportunity presented itself.”
“Terrina has a vast knowledge of regulatory affairs requirements on a global level. While I worked with Terrina she quickly and successfully registered Medical X-Ray Equipment in the European, US, Asian Pacific and Latin American Countries. She successfully obtained a Certificate of Exportability (801e) from the FDA allowing sales outside of the US to bring in revenue while we awaited US release to market. Terrina is professional, team oriented and works in a synergistic manner with those on the project ensuring speed to market for new products. I would hire Terrina knowing that she has the expertise, drive, enthusiasm and commitment to getting products registered worldwide in a practical, cost efficient and timely manner.”
Latest News
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Health authorities such as FDA are commissioned to address consumer health concerns and ensure safe and effective products are placed…
Our Certification
DUNS: 081137423, CAGE Code: 844L5
NAICS Codes: 541611, 541613, 541614, 541618, 541690, 541714, 541715, 541990, and 611430
PSC Codes: AE16, AE26, AE27, AH96, AJ16, AJ51, AJ56, AL16, AM16, AN16, AZ16, R425, R431, R704, R799, and U001