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Rely on EDGE to help negotiate the complex maze of regulations and guidance

Government Agencies

USDA Center for Veterinary Biologics
Contact Information

General Contact Information

Organizational Charts

Commonly Used Guidance

Title 9–Animals and Animal Products Parts 101 to 123 (the rules)

Veterinary Services Memorandums (guidance toward compliance)

Supplemental Assay Methods (SAMs) (Advice and instructions on testing procedures)

Policy Manual – Inspection and Compliance (CVB current thinking on key policies)

Policy Manual – Policy, Evaluation and Licensing

Commonly Used Forms

Biologics Forms (APHIS Forms 2007, 2008, 2015 etc.)

Risk Analysis for Veterinary Biologics (SIF’s)

Import and Export of Biological material, vaccines and controlled information

Import-Export of Biological Products

Department of Commerce Export Administration Regulations (EAR)

Canadian Centre for Veterinary Biologics

Veterinary Biologics Memoranda

Guidelines and Forms

European Medicines Agencies
Committee for Medicinal Products for Veterinary Use (CVMP)

EMA Guideline for veterinary vaccines (IVMPs)

GMP for Veterinary Vaccines

Trade Organizations

United States Animal Health Institute

United States Association of Veterinary Biologics Companies (AVBC)

Animal Health Europe

CONTACT US
Paul Hauer
phauer@edgevcg.com
(515) 291-4758
Carolyn Ross
cross@edgevcg.com
(515) 351-8669
Questions about Invoicing?
Contact cross@edgevcg.com
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