About Us

Founded in 2013 by Hans Draayer, Larry Elsken and Donna Gatewood, EDGE Veterinary Vaccine Consulting Group is built on the principle that combined industry and agency experience gives us the depth, flexibility and insight to address any of your regulatory questions.

CONTACT US

Regulatory Support for
Veterinary Biologics

Veterinary biologics, under the jurisdiction of the USDA-CVB, range from conventional and recombinant vaccines to antibodies and immunotherapeutics as well as some diagnostic products.

We have experience and expertise to cover the entire range of products and regulatory needs for your firm including:

Regulatory support across all stages of biological product development from start-up of a new USDA Establishment, Product Licenses, Master Seed SIFs, Production Outlines, Development Plans, protocols, reports, and product labeling.
Regulatory support for all aspects of product manufacturing and sales, including production outline reviews, facility inspections, label revisions, deviation reporting, advertising and promotion review, and Quality Management System review.

Product
Development

Biological product development plans with risk-based options for acceleration and provision of product licensing plans in accordance with USDA-CVB policy, including:

  • Jurisdictional review of products (FDA or USDA-CVB?)
  • Input on study design and statistical review
    Support of diagnostic product licensing

Product Life Cycle Support

REGULATORY SUPPORT

Provide administrative support to sites for regulatory tasks such as Annual Outline Review and updates to Blueprints and Legends. We also provide regulatory support for other post- licensure activities, such as reference requalification, including in vitro.

MERGERS AND ACQUISITIONS
Provide strategic and regulatory support to manage regulatory aspects of mergers and integrations, including veterinary biologic license transfers, label revisions, certificates of licensing and inspection and production site transfers.

Quality Management and Improvement

Review quality systems and deviation reporting for manufacturing investigations.
Prepare sites and personnel for regulatory inspection of facilities, including mock inspections.
Assist with correction and action planning for site compliance remediation.

Training and Personnel Development

We provide training related to veterinary biological product development, registration, production, and quality.

Programs developed to meet your needs ranging from 1- to 2-hour overviews to full day, on-site training programs