September 16, 2020
Building Medical Device Innovations Together
“We need to convert from Human Cells, Tissues, and Cellular & Tissue-Based Product (HCT/P) designation to a Biologics License Application (BLA).”
We are more than just consultants, medical writers, or regulatory specialists working on a project for you. Instead, we partner with you to ensure our services are customized to your needs. Think of us as an extension of your team, helping you every step of the way to achieve your own telos– or ultimate goal.
We demystify the complexities of regulatory pathways and quality systems to provide a concrete path-forward.
Utilizing a full range of scientific tools, we create and communicate evidence to demonstrate your product’s value proposition.
Our strategic approach provides clear steps to reimbursement by defining the medical needs, clinical benefits, and economic insights for payers.
Telos by the Numbers
FDA Clearance or Approvals
Meetings with Regulatory Bodies
Scientific Protocols Developed
Clinical Studies Run
Pre-Clinical Studies Run
“Telos pulled us out of the fire a bunch of times. There were times that I called Telos and said that I need this and this by this date… and they would always deliver. Telos’ flexibility and their ability to hit deadlines to turn things around quickly was a game changer.”
Telos works with you to clearly understand your business’ goals. We ask “Why” instead of “How.”
Our team identifies service areas where we can partner to create a plan unique to your business.
We’ll work with you through each phase to accomplish the milestones identified in the plan.
Because we see each client as a true partner, we remain ready to help your business scale as new needs arise.
Your products’ success starts with the foundations of pre-clinical, clinical, and health economics evidence.
We leverage a wide range of analytical approaches and forums of communication to convert your data to disseminated evidence.
Still need to collect the data? Our Clinical Research Organization (CRO) provides a full suite of clinical research services to support your studies from strategic trial design through completed reports.
Whether seeking novel indications or aiming for first-time marketing approval, our expert regulatory and quality teams will help you win in a competitive landscape.
Our experts provide your team access to over 40 years of regulatory and quality subject matter expertise globally and ensure you have round-the-clock compliance to stay ahead.
Our evidence, CRO, regulatory, and quality services operate in a unique, integrated fashion to achieve your ultimate goals by circling-up around each objective.
Instead of providing services, we work to provide intrinsic value to your success. View our case studies to see how we’ve helped clients just like you:
September 16, 2020