Venture Zebra Group

Consulting Services for the In Vitro Diagnostic Products Industry

In vitro diagnostic (IVD) products consist of medical devices, chemical substances and biological agents used to analyze tissue or fluid samples taken from the human body. They aid in the detection of pathology and are crucial to disease mitigation, cure and sequelae prevention. They may also be used for medical research. IVDs are strictly regulated to assure the public of their safety and effectiveness. Without help, manufacturers that seek to market IVDs in vast territories, such as the US and China, may find themselves overwhelmed with the voluminous registration requirements.

IVD consultancy is essential to the early success and sustainability of these products in the market. Reliable IVD services aid customers in all stages of the product life cycle and ensure that the FDA or NMPA approval process is expedited and precisely done. They not only enable you to cut costs but also allow you to sell your products with minimal delay.

VZG offers the following IVD consulting services:

  • FDA document submissions, which include but are not limited to establishment registration, 510(k), device listing, investigational device exemptions (IDEs), pre-IDEs, premarket approvals (PMAs), laboratory-developed tests (LDTs) and biologics applications (BLAs)
  • Interfacing during FDA meetings and negotiations
  • Ensuring US CLIA regulatory compliance
  • Determining inspection-readiness by simulating inspections by the US FDA and other regulatory organizations
  • Resolution of US FDA warning letters, consent decrees and 483 forms
  • VZG shall help with the appropriate classification of IVD products
  • VZG will serve as their Agent in China and liaison to the NMPA
  • Help secure a notarized proof of qualification of the manufacturer, such as an ISO 13485 Certificate, US FDA Establishment Registration, Japanese manufacturing license and other
  • Assistance in global product registrations, which include Canada, the European Union, Asia-Pacific, Africa, the Middle East and Latin America
  • Development and implementation of quality system regulatory compliance protocols
  • Training in the preparation of technical documentation for IVDs
  • Planning and implementation of procedures for investigating IVDs’ performance and supporting clinical evidence for their use
  • Leadership training in project management and product development

Why Choose VZG?

Comprehensive Service

VZG offers a comprehensive package of consulting and management solutions for every need in the IVD manufacturing industry.

Unparalleled Technical and Legal Expertise

Our highly proficient team of consultants shall guide you in all the technical aspects of product development. Their years-long experience in regulatory compliance is likewise at your disposal.

Client Advocacy

We are committed to optimizing the registration process and getting your IVD product in the market in the shortest time possible.