Solutions for your unique animal health challenges
Medical Writing
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Obtaining start-up funding for early revenue companies is instrumental to business success.
Several of our PEAK specialists have received federal grants and understand the mechanics of writing competitive applications for multiple funding agencies (SBIR/STTR, NIH, NSF, DoD, etc.) and can help you obtain non-dilutive funding through federal grant mechanisms.
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Our scientists have a breadth of knowledge regarding preparing nonclinical protocols for IACUC submission and grant review. PEAK writing services can optimize your in vivo research project from a regulatory perspective to streamline the protocol review process, while supporting animal welfare.
After study completion, we can assist in preparing final reports to include in your submission package.
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Publishing your findings in a peer-reviewed journal can improve consumer perception of your product and if appropriate, certain data can be used to support your regulatory submission.
Let the seasoned experts at PEAK help you navigate the process of authorship.
Preclinical Research Design and Execution
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Our consultants have extensive experience with IACUC operations and our licensed veterinarians can be contracted to serve your organization or institution as attending veterinarians, ad hoc consultants, or IACUC members to ensure regulatory compliance with USDA and OLAW.
Additional services:
Establishing a program of veterinary care with regularly scheduled on-premise visits
Conducting semi-annual facility inspections
Providing CE and training to animal care staff, research scientists, and other personnel
Writing and reviewing contingency plans for disaster preparedness
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PEAK consultants have advanced training in comparative medicine which provides a foundation for animal model selection and allows for logical development of novel animal models of disease. To increase the likelihood of product translation, sponsors should start by selecting an appropriate model.
The PEAK team includes several consultants with working knowledge of Institutional Biosafety Committees (IBCs) and BSL-3 level pathogens, which may be valuable to your drug development research projects.
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The PEAK team includes professionals with experience designing and managing veterinary clinical trials. Along with establishing proper study design, our scientists can ensure best practices for ethical participation and Good Clinical Practices (GCPs) are followed.
PEAK can help you identify veterinary clinical sites by performing feasibility assessments to ensure selected sites can meet your study needs. Our study monitors perform site visits to ensure data management systems are in place and that documentation is being collected appropriately.
Regulatory Affairs and Quality Assurance
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Based on your specific goals, PEAK specialists address requirements and potential obstacles for market access and distribution and perform an analysis of the regulatory environment.
We maintain working relationships with governmental and non-governmental organizations in the regulatory affairs space to provide effective guidance.
We provide on-site or remote training to clarify expectations and to ensure organization-wide compliance.
We assist in the development of SOPs.
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PEAK specialists can assess proposals to regulatory authorities, compile pre-submission reports, and monitor implementation of regulatory strategies. We provide guidance on pre-approval and GCP inspections.
Regulatory Guidance: We lead cross-functional teams for interactions with regulatory authorities, including panel meetings.
Review Process Management: We ensure that nonclinical data are consistent with the regulatory requirements and support product claims.
Submission Management: We support the preparations of dossiers and submission packages for regulatory agencies.
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Our QA team can perform independent auditing services to determine if scientific research is conducted in accordance with Good Laboratory (GLP) and Good Clinical Practice (GCP) guidelines and regulations.
