Veterinary Pharmaceutical

Animal health products are a growing segment of the overall healthcare market, and we have developed expertise in several areas to support this market evolution. Whether you need help navigating the regulatory agencies, or are scaling up your facility for production, we can help.

Our veterinary pharmaceutical consulting services include

  • Assist clients in navigating the approval process for both generic (ANADA) and pioneer (NADA) products
  • Represent clients during meetings with the USFDA Center for Veterinary Medicine (CVM)
  • Short and long term R&D planning
  • Project Management
  • Protocol development, study report preparation, review and edit study reports
  • Assist with planning target animal safety and clinical/effectiveness studies
  • Monitor safety studies
  • Prepare and submit chemistry, manufacturing and controls (CMC) technical sections
  • Drug product submissions (NADA/ANADA, INAD, JINAD, VMF/DMF, DERs, MCSRs)
  • Background with veterinary drug product submissions to Canada
  • FDA liaison for product submissions & quality compliance
  • Submit regulatory documents through CVM’s Electronic Gateway
  • Assist with product recalls
  • Perform gap analysis of regulatory documentation
  • Prepare responses to 483 reports & warning letters;  assist in mitigating violations
  • Review labeling to help assure compliance
  • Facility CGMP and due diligence audits
  • Personnel training and facility preparedness for regulatory inspections
  • Validation master plans, processes & practices