1. Expert support throughout the biologics
development process — competitive
advantage for your biotechnology product
Who should partner with us?
Biotechnology, pharmaceutical, and medical device companies and their partners that
require additional resources in development, preparation of regulatory documentation,
training, auditing, or postapproval support should partner with us. Companies can use
our expertise to facilitate multinational approvals and achieve greater returns on
development investments.
Regulatory Sciences
Biotechnology consulting services
Cardinal Health
Specialty Solutions
Our services
• Product development and
registration strategies
• Data review and gap analysis activities
• Program management
• Facility inspections, including Good
Manufacturing Practice (GMP), Good
Laboratory Practice (GLP), Good Clinical
Practice (GCP), and Current Good Tissue
Practice (cGTP)
• Validation consulting
• Global regulatory strategies
Pre-IND and IND
• CMC development consultation
• Pharmacology/toxicology guidance
• Nonclinical development consultation
• Clinical development consultation
• Preparation for pre-IND meetings
• IND preparation, review, and publishing
in eCTD format
• Preparation of IND amendments and
annual reports
• Preparation of responses to CBER
Pre-BLA and BLA
• Review of nonclinical, clinical, and
CMC data
• Preparation for pre-BLA meetings
• BLA preparation, review, and submission
in eCTD format
• Electronic content management
• Preparation of responses to CBER
• Electronic labeling (SPL/PLR)

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 theproperty of their respective owners. Lit. No. 1SR14-18603 (08/2014)
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
• Antibodies
• Antisense oligonucleotides
• Oligonucleotides (DNA and RNA)
• Aptamers
• Blood derivatives
• Cells (manipulated)
• Cells (transplanted)
• Genetically modified
microorganisms
• Genetically modified viruses
• Gene therapy
• Proteins
• Recombinant peptides
• Synthetic peptides
• Vaccines
Our expertise
Helping you get your biotechnology-derived
products to market faster
• Regulatory application preparation
• Interaction with regulatory authorities
• Compliance services
• Postapproval support
cardinalhealth.com/regulatorysciences
For more information about biotechnology consulting
services, 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