Compliance, Regulatory & Quality Consultants

The mission statement for FDA’s Center for Veterinary Medicine (CVM) reads: “Protecting Human and Animal Health.” To achieve this broad mission, CVM makes sure an animal drug is safe and effective before approving it. The center approves animal drugs for companion (pet) animals, such as dogs, cats, and horses; and for food-producing animals, such as cattle, pigs, and chickens. If the drug is for a food-producing animal, before approving it, the center also makes sure that food products made from treated animals (e.g. meat, milk, and eggs) are safe for people to eat. The CVM also Makes sure food for animals—which includes animal feed, pet food, and pet treats—is safe, made under sanitary conditions, and properly labeled.

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Aware of FDA's mission, CFR Compliance LLC™ assist companies in assuring that every product developed, manufactured and marketed for animal use is safe and effective. Our staff and associated professionals assist with regulatory filings for animal food and drug approvals, as well as systems optimization and regulatory compliance. We monitor safety and effectiveness of animal drugs on the market, and review advertisement materials for their compliance to FDA, FTC, and USDA. Some of our services:

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Regulatory Affairs

• Regulatory Strategy

• Investigational New Animal Drug (INAD)

• New Animal Drug Application (NADA)

• Abbreviated New Animal Drug Application (ANADA)

• Notice of Claimed Investigational Exemption (NCIE)

• Import and Export 

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Good Manufacturing Practices - GMP

• Remediation for Form 483, Warning Letter and Consent Decree

• Drug specification development

• PreApproval Inspections (PAIs)

• Process/Product Transfer and Engineering

• Process Validations

• Supply Chain and US Customs Compliance

• GMP Inspection support

• GMP Training

• Quality Engineering

• Six Sigma Black Belt Project Management