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Our focus: Drugs, Medical Devices and Combination Products 


 CreaBio Healthcare Innovation Partners is dedicated to support healthcare industries building and documenting their clinical and regulatory files.

  We apply, best practices in Design Control, deploy the right tools to document and support the Technical Dossiers, as well as, Health and Hazard Risk Management and Risk/Benefit Analysis, in full compliance with US and European applicable Regulations and Standards.

  We collaborate directly with your teams involved in New Product Design, Development, Regulatory, R&D and Quality Assurance.

 

Regulatory services


  • Regulatory strategy design and planning per targeted countries.
  • Gap analysis for country market authorizations (EU & US).
  • Regulatory and quality document reviews from existing technical dossier.
  • Support for conducting health and hazard risk management; Use-FMEA; Design-FMEA; Process-FMEA and risk management plan report with risk/benefit assessment for each residual risks.
  • Support for creating and documenting users’ requirements file, regulatory matrix; product development plan; product functional analysis; design input and design output files; design traceability matrix; design reviews; design approval process and design history file.


Clinical services


  • Human factors evaluation services enabling to document product safety and effectiveness.
  • Support for clinical trial design and implementation working with sponsors to ensure all drug and device supportive documentations are correct, prepared and reviewed.
  • Support for filling clinical trial application with domestic and international regulatory agencies; ensuring submissions comply with applicable regulations and standards for each region and later tracking of registration process.


Value creation engine


SINGLE SHOP SERVICES

  • Users’ requirements;
  • Regulatory strategy and requirements;
  • Design control from conception to design transfer;
  • Health risk management and product safety;
  • Clinical and human factors verification and validation;
  • Design history file setting.

BENEFITS  “4 R Rule”

  • Do what is RIGHT according to the applicable regulations and standards requirements.
  • Do what is REQUIRED at the right time.
  • Do what is ROBUST to satisfy quick market access and users’ adoption.
  • Do what is REWARDING for creating economic value.

OUR COMMITMENTS

  • Create trust and loyalty with our partners / customers.
  • Carefully select our partners / customers to ensure best and efficient services in due time.
  • Engage our dedicated experts to you ensuring long lasting service reliability and consistency.