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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
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
Regulatory strategy- Participate in IDE, 510(k), and PMA submission preparations
- Formulate responses to study-related questions from the FDA
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
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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