David A. Espeseth, Veterinary Biologics Consultant
Assisting licensed manufacturers, license applicants, and importers of Veterinary Biologics with USDA, APHIS, Center for Veterinary Biologics regulatory requirements.

Services
Provided

Regulatory Services:
* License and Permit Applications for New Products and Facilities.
        - Licensing/Permitting Strategies
        - Explanation of APHIS
          Expectations and Policies
        - Assistance in Responding to
          APHIS Questions
        - Guidance on APHIS Interactions
        - Preparation/Review of Documents
              Application forms
                 Research protocols
                 Outlines of Production
                 Labeling
                 Supporting data
                 Blueprints and legends

* Interpretation of APHIS Regulations and Guidelines.
        - Expert Witness
        - Issue Resolution/Problem Solving
        - Compliance Strategies
        - Regulation Writing
        - Correspondence

* Assessment of Licensing Activities.
        - Quality of Submissions
        - Efficiency of Licensing Activities
        - Reviewer Relationships


Training Services:
* Regulatory Statutes and Guidelines
         - Virus Serum Toxin Act
         - Title 9 Code of Fed. Regs.
         - Veterinary Services Memos
         - CVB Notices

* APHIS Licensing Requirements & Procedures
         - What APHIS Wants & Why