1. Chemistry,
Manufacturing
and Controls
The chemistry, manufacturing and controls (CMC) experts at Cardinal
Health Specialty Solutions provide consulting services that yield
efficient regulatory approaches to pharmaceutical, biologic and
medical device development. We partner with you to develop your
regulatory strategy, as well as author, prepare, review and submit
CMC documentation for all phases of development. Our CMC
experts have experience with complete analytical and formulation
development programs, from initial development to production of
clinical and commercial supplies for small and large molecules.
The diverse expertise of our CMC team includes:
• Small molecules (℞ and over-the-counter [OTC] products)
• Biologic products (including monoclonal antibodies, proteins, oligonucleotides,
synthetic peptides, cell- and tissue-based products, stem-cell-based products,
vaccines, gene therapy and blood and blood-derived products)
• New chemical entity, generic and biosimilar development
• Human and veterinary product development
• Medical devices and drug/device combination products
• Products in all major dosage forms
Cardinal Health
Specialty Solutions

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Our solutions
Regulatory • Development of global regulatory strategies for synthetic and biologic products
• Development, preparation and maintenance of global regulatory submissions
(including Module 2 QOS, Module 3 and labeling)
• Preparation and maintenance of Drug Master Files
• Guidance with FDA and global regulatory health authority requirements, regulations and guidances
• Interactions with FDA and global regulatory health authorities, including information requests
and meetings (eg, pre-IND, end-of-phase 2, pre-NDA and pre-BLA)
• Support for pre-approval inspections of manufacturing facilities
• Development and maintenance of post-approval documentation (eg, annual reports,
Post-Approval Supplements (PASs), Changes Being Effected (CBE) and Type I and II variations)
• Management of active pharmaceutical ingredient (API) and drug product development programs
• Due diligence reviews and gap analyses of development programs, marketing applications and
manufacturing sites
• Guidance on API process development and optimization
• Guidance on biologic drug substance development and manufacturing
• Formulation development for small and large molecules
• Analytical method development and validation for small and large molecules
• Management of clinical trial material production
• Support for manufacturing process validation
• Development of quality assurance programs, including quality systems and standard operating procedures
Pharmaceutical and
biopharmaceutical
development
For more information about our
chemistry, manufacturing and controls services, visit us at
cardinalhealth.com/regulatorysciences or call us at 913.451.3955.
How our solutions help
Our CMC experts help you ensure that your final drug product meets the regulatory
compliance and quality standards of FDA and global health authorities at each clinical
phase and commercial launch. We have a track record of successful interactions with
regulatory authorities worldwide and nearly four decades of experience in scientific
and regulatory consulting and regulatory submission operations.