business

In vitro diagnostic development support business

We provide multiple service ranging from seeds assessment, clinical research , advanced medical care and regulatory affairs regarding IVD.

Seeds Assessment

We assess values of seeds from expertise point of view.

Organize vision of seeds
  • Clarify purpose of diagnosis
  • Clarify how to use it in actual clinical situation.
  • Clarify differences from other already existing diagnostic drugs and diagnostic systems
Consideration of Potentiality in market.
  • Analyze Intellectual property states (including research of competitive intellectual property)
  • Rationality of Cost-effectiveness of IVD
  • Method on how to package in convenience way
Research and Development Support
  • Confirmation of data acquisition
  • Positive/Negative、True/False
  • Development timeline and required cost calculation
  • Proposal of Milestones
Supplementary research ･ Pilot study ･ Performance support
  • Proposal of Plan for supplemental data acquisition to conduct clinical researches and clinical studies
  • Biological Sample Collection

Support for Clinical Study

We make marketability as IVDs clear and make the development process optimized in line with clinical data acquisition at early stage.

Proposal of plan for Clinical research development
  • Proposal of Application for subsidy
  • Support for Preparation of clinical research protocol
  • Support for clinical study complied with GCP (including judgement whether GCP is applied for a clinical study or not). If applicable, clinical data to be utilized in application for approvals is predicted in our service.
  • Support for Clinic/sites selection and negotiation
  • Support for Ethics committee ･ IRB consent form preparation, research report-related form preparation, and other required documents preparation to submit ethics committee
  • Support for Clinical research monitoring, progress management, data management (sending clinical monitors )
  • Support for selection and introduction of Business partners

Support of Advanced Medical

There are a lot of opportunities in which IVDs under development could be assessed in actual clinical scenes in accordance with advanced medical care program

Support for clinical study complied with GCP
  • Clinic/sites selection and negotiation
  • Clinical research monitoring, progress management, data management (Dispatching temporary clinical monitors )
  • Selection and Introduction of Business partners

Support for Regulatory Affairs

Support for creating applications for approvals

Support for discussion with PMDA (Pharmaceuticals and Medical Devices Agency)
  • Creating of Protocol
  • Proposal of Strategy for reimbursements
  • Creating application applications for approvals
  • Support of Pre-consultation for Regulatory Affairs
  • Support of discussion with Health, Labor and Welfare
Support for discussion with FDA (Food and Drug Administration)

We provide the best service cooperating with a business partner “InfiniteBio,Inc”.,.

  • Creating application applications for approvals
  • Support of FDA correspondence

For detailed documents, any inquiries or comments about In vitro diagnostic development support business, please contact us via the inquiry form below.

Inquiry Form