Animal Feed, Pet Food & Animal Medications
Just as with products intended for human use, FDA’s Center for Veterinary Medicine (CVM) regulates animal feed/pet food and animal medications sold in the US. Products undergo the same scrutiny and have similar regulatory requirements, including GRAS, Food Additive Petitions, New Animal Drug Applications, Medicated Feed Mill Licenses and more. In addition, State Feed Control Officials have a strong regulatory hand in enforcing the American Association of Feed Control Official’s (AAFCO/s) ingredient and labeling requirements for animal feed/pet food.
EAS offers on-site assessment services for pet food, animal feed and animal drug manufacturers and distributors. Our highly skilled independent consultants provide solutions to your CVM and AAFCO regulatory challenges, offering a seamless approach to submissions, development of Good Manufacturing Practices, evaluation of ingredients and labels, and more.
Overview of Veterinary Services
Veterinary Pharma Submissions of NADA and ANDA
EAS assists clients with reviews of NADA and ANDA submissions to FDA, including assessments of data and reports, appropriateness and completeness of formatting. EAS can submit these submissions on client’s behalf through the FDA electronic gateway offering a smooth communication process between FDA reviewers and the client.
Veterinary Food Submissions for GRAS and Food Additives
CVM, as well a State Feed Control Officials, evaluates ingredients for pet food and animal feed. While there is no pre-submission requirement to CVM for animal feed, pet food ingredients or labels, a number of states do require these pre-submissions as well as registration with FDA under FSMA prior to introducing an animal feed or pet food into the US market. EAS assists importers and manufacturers with FDA registrations as well as any state-based permitting and licensing. In addition, EAS provides expert regulatory assistance for manufacturers or sponsors who intend to submit a Food Additive Petition to FDA for acceptance of a new animal food additive or for a new use of an already approved animal food additive. Our toxicologists prepare GRAS submissions for pet food and animal feed products, assessing the safety and acceptability of ingredients, and offering a full spectrum of services from safety studies through the FDA submission and review process.
Good Manufacturing Practice Regulation Audits
Good Manufacturing Practices (GMP) are critical to the safety of CVM regulated products. Those who participate in the Manufacturing, Packaging, Labeling or Holding Operations for these products must follow certain practices to ensure quality. EAS conducts GMP audits, both desk and on-site assessments and mock FDA audits providing a summary of findings and any necessary improvements requiring corrective action plans. We also provide detailed GMP training to management and staff as required by the regulations.
Veterinary Product Labeling and Claims
EAS’ labeling team offers services to the pet food and animal feed as well as veterinary drug and OTC industries. Much like products for human use, products for animals are tightly regulated ensuring safety and appropriate labeling, claims and marketing statements.
Animal Food Safety – Food Safety Modernization Act
FSMA is the largest change the pet food and animal feed industry has seen since the inception of FDA. EAS is your one-shop consulting stop for all of your pet food and animal feed veterinary services with an experienced staff and group of specialized Independent Consultants that can quickly engage and address your questions and compliance needs.
EAS Testing Partner, FSNS Offers Unparalleled Services
FSNS has a long tradition of delivering service and science to the food industry, including meats and dairy, through their investments in quality systems and industry leading technical expertise. By partnering with customers and industry leaders across all segments, FSNS can provide you the testing and guidance your organization needs to navigate in an ever changing regulatory and global supply chain environment and enable your business to reach its full potential. They also provide services for full nutritional panels and food analysis using the major international method indexes, pharmacopoaes, and published methods with the backing of significant scientific consensus.
Expect more from your and regulatory testing partners.
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