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FAST TRACK CRO
in Ukraine

A favorable and pleasing regulatory environment makes it advantageous to carry out CRO procedures in Ukraine. Fast Track system ensures the efficient delivery of innovative medical products on the Ukrainian market.

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Acceleration of Medical Device Development

Traditional development approach before the CE marking and product launch on the market.

Concept

Planning

  • Product development planning
  • Risk analysis
  • Requirements
  • Prototyping
  • Test method development
  • Production process development

Development

  • Detailed design
  • Prototypes and tests
  • Production process development and validation

Verification

  • Design freeze
  • Pilot manufacturing

Pre-Production

  • Clinical trials
  • Technical file or design dossier reparation and NB submission

Production and Marketing

  • CE marking
  • Product launch

In case of less complicated and low-risk devices, problem identification and device development along with testing, takes about 1 to 2 years. Moreover, another 1 to 2 years are required for product delivery to the EU market. Fortunately, the duration of these procedures can be shortened to 12-16 months through the Fast Track plan that we provide.

In general, the Fast Track process can be divided into several stages:

Gathering and analysis of relevant scientific literature on a medical product that is required for its Clinical Evaluation Report along with the draft of the Clinical Evaluation Report.

Conducting a conformity assessment of the medical device following the Ukrainian regulatory requirements and the product launch on the market.

Gathering follow-ups through the post-market surveillance and extension of the Clinical Evaluation Report utilizing the clinical experience data.

Moreover, Fast Track has undeniable benefits, including the following:

Favorable timeline

No need to obtain special clinical study approvals

No requirement for ethics committees reconciliations

No necessity of adherence to special patient recruitment procedures or insurance issues

Cost-effective budget

To get further information on Fast Track CRO, do not hesitate to contact us!

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CONTACT Us

33B, Shota Rustaveli str., Kyiv, 01033, Ukraine

+380 (95) 692 26 08

daria.abulova@jerelo.eu

Mon - Sat | 9am - 8pm

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