Client Ask: “(what was Axoltol’s need) “

Client: Bioprinting for tissue engineering and regenerative medicine

Initial Service Areas Identified:

tissue engineering,regeneratvie medicine,regulatory strategy,regulatory-and-quality-services,partnered

Client Ask: “(what was Axoltol’s need) “

Client: Bioprinting for tissue engineering and regenerative medicine

Initial Service Areas Identified:

tissue engineering,regeneratvie medicine,regulatory strategy,regulatory-and-quality-services,partnered

“Client Quote/Testimonial”

How We Partnered

  • Regulatory landscape and strategy
  • Internal audits
  • Q-submissions and FDA interaction
  • Clinical study IDE, IND applications
  • 510(k), De Novo, PMA, BLA
  • Breakthrough or RMAT designation
  • Quality systems, SOPs, MDSAP
  • MDR Gap analysis and strategy
  • PMS and PMCF procedures
  • CE Mark
  • Technical files
  • Clinical Evaluation Reports (CERs)

Services Provided as a Result of Our Integrated Approach

  • Regulatory & Quality Services 100% 100%
  • Evidence Services 65% 65%
  • Clinical Research Services 80% 80%

Client Successes & Results of Partnering with Telos

tissue engineering,regeneratvie medicine,regulatory strategy,regulatory-and-quality-services,partnered
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Bonus Outcomes & Competitive Advantage Gained

Main Bonus Outcome here

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