BioAssist, Inc.


Preclinical Testing Services

Services

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Nonclinical Study Services
Medical Device/Technology Assessments
Regulatory Affairs
Veterinary Specialty Services
Technical Writing

Nonclinical Study Services

Animal studies play an important role in the regulatory process for Class II and III medical devices and combination products. In order to reach reasonable regulatory target dates it is important to include in your team those who have the appropriate credentials and experience in conducting feasibility and Good Laboratory Practice (GLP) studies. Our preclinical experience with Class II and III devices, familiarity with the GLP regulations, knowledge of the regulatory pathways for these device classes, and our specialty veterinary training in large and small animal surgery, anesthesiology and critical patient care allow us to contribute in a unique way. We understand the key steps involved in feasibility and GLP studies. As study directors for studies performed in compliance with GLP regulations, we have been responsible for assuring that GLP regulations were followed. In addition, both principals have achieved certification by the Society of Quality Assurance as Registered Quality Assurance Professionals Good Laboratory Practice (RQAP-GLP), which allows us to facilitate the QA process. In addition to providing testing facilities responsibilities, we provide the following services:
  • Animal model development
  • Troubleshoot ongoing studies
  • Literature search of idea and review of related FDA guidance documents
  • Participate in discussions regarding regulatory strategy
  • Perform comparative anatomy reviews
  • Study design
  • Protocol and study form development
  • Prepare study procedure reports
  • Develop and implement postoperative chronic monitoring guidelines
  • Perform data analyses
  • Final report preparation

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Medical Device/Technology Assessments

  • Review and analysis of current treatment strategies for diseases

  • Comparison and analysis of competitor devices
  • Analysis of alternative and additional applications
  • Prototype review
  • Physician acceptance reviews
  • Due diligence of results of nonclinical studies
  • Device and technology assessments for venture capital funds
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Regulatory Affairs

  • Regulatory strategy

  • Participate in IDE, 510(k), and PMA submission preparations
  • Formulate responses to study-related questions from the FDA
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Veterinary Specialty Services

BioAssist principals are specialists in veterinary surgery and anesthesiology. Through our private practice, academic and corporate positions, we have gained extensive experience with both small and large animal species. Our services in the veterinary specialty service area include:
  • Consultation services for the private practice veterinary community involving individual animals or situations
  • Customized consultation services for the research community involving anesthesia, surgery, analgesia, monitoring and critical patient care
  • Anesthesia services for the research or private practice community
  • Cardiopulmonary bypass perfusionist services for the research or private practice community

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Technical Writing

As study directors, we have been directly responsible for documentation, analysis, interpretation and reporting of results of nonclinical medical device safety studies in the form of final GLP reports. In addition, during our academic careers we have prepared research grant applications and manuscripts for peer-reviewed journals. Our services in the technical writing area include:
  • Summarize results of feasibility studies to assist in further fund raising
  • Prepare study-related reports
  • Organize and write manuscripts for peer-review journals

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