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Competitive advantage for
your animal health products
•	 Expert product development support
•	 Experienced partner for the life cycle
of your product
Who should partner with us?
Animal health pharmaceutical, biotechnology, and medical
device companies and their partners, with needs for additional
resources in development, preparation of regulatory documentation
(preapproval and postapproval), training, and auditing, should
partner with us. Companies can use our experience to obtain greater
returns on investments.
Our services
•	 Product development consulting
•	 Integrated scientific, regulatory, and business strategies
•	 Data review and gap analysis preparation
•	 Management of contract manufacturing organizations
•	 Facility inspections
•	 Validation consulting
•	 Preparation and submission of regulatory documentation
(paper and electronic formats)
•	 Electronic content management
•	 Interaction with regulatory agencies
Regulatory Sciences
Animal health product development
Cardinal Health
Specialty Solutions
© 2014 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO
and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All
other marks are the property of their respective owners. Lit. No. 1SR14-18604 (08/2014)
Integrated scientific and regulatory
strategies for your animal health product
•	 Faster to market for your animal health product
•	 Greater returns on your investments
Our expertise
•	 Animal health product development
•	 Preparation of Investigational New Animal Drug Applications (INADs)
•	 Preparation of New Animal Drug Applications (NADAs)
•	 Preparation of Abbreviated New Animal Drug Applications (ANADAs)
•	 Postapproval support for NADAs and ANADAs
•	 Veterinary product manufacturer compliance
•	 Electronic submissions
How we help
•	 A track record of successful interaction with regulatory authorities
worldwide
•	 Nearly four decades of experience in scientific and regulatory
consulting and regulatory submission operations
•	 Experience in all major therapeutic areas and all classes of
pharmaceutical products, with more than 100 product approvals,
including pharmaceutical, biologic, generic, over-the-counter,
combination, and veterinary products
•	 A strategic global approach to regulatory planning and
product development
•	 Continuity of service from the laboratory bench to the pharmacy
shelf and beyond
•	 A commitment to quality, efficiency, and our clients’ needs
•	 The leveraged resources of a Fortune 22 company
cardinalhealth.com/regulatorysciences
For more information about aminal health product development,
visit us at cardinalhealth.com/regulatorysciences or call us at
913.451.3955.
Cardinal Health Regulatory Sciences
7400 W 110th St., Suite 300
Overland Park, KS 66210

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CHRS Animal Health Brochure

  • 1. Competitive advantage for your animal health products • Expert product development support • Experienced partner for the life cycle of your product Who should partner with us? Animal health pharmaceutical, biotechnology, and medical device companies and their partners, with needs for additional resources in development, preparation of regulatory documentation (preapproval and postapproval), training, and auditing, should partner with us. Companies can use our experience to obtain greater returns on investments. Our services • Product development consulting • Integrated scientific, regulatory, and business strategies • Data review and gap analysis preparation • Management of contract manufacturing organizations • Facility inspections • Validation consulting • Preparation and submission of regulatory documentation (paper and electronic formats) • Electronic content management • Interaction with regulatory agencies Regulatory Sciences Animal health product development Cardinal Health Specialty Solutions
  • 2. © 2014 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. Lit. No. 1SR14-18604 (08/2014) Integrated scientific and regulatory strategies for your animal health product • Faster to market for your animal health product • Greater returns on your investments Our expertise • Animal health product development • Preparation of Investigational New Animal Drug Applications (INADs) • Preparation of New Animal Drug Applications (NADAs) • Preparation of Abbreviated New Animal Drug Applications (ANADAs) • Postapproval support for NADAs and ANADAs • Veterinary product manufacturer compliance • Electronic submissions How we help • A track record of successful interaction with regulatory authorities worldwide • Nearly four decades of experience in scientific and regulatory consulting and regulatory submission operations • Experience in all major therapeutic areas and all classes of pharmaceutical products, with more than 100 product approvals, including pharmaceutical, biologic, generic, over-the-counter, combination, and veterinary products • A strategic global approach to regulatory planning and product development • Continuity of service from the laboratory bench to the pharmacy shelf and beyond • A commitment to quality, efficiency, and our clients’ needs • The leveraged resources of a Fortune 22 company cardinalhealth.com/regulatorysciences For more information about aminal health product development, visit us at cardinalhealth.com/regulatorysciences or call us at 913.451.3955. Cardinal Health Regulatory Sciences 7400 W 110th St., Suite 300 Overland Park, KS 66210