Cardinal Health Specialty Solutions provides expert chemistry, manufacturing and controls (CMC) consulting services, from a regulatory and quality assurance perspective, to help you achieve compliance with global regulatory requirements and quality standards.
Areas of expertise
Our CMC experts specialize in the management of analytical methods, formulation development studies and manufacturing data used to support product development and change controls. We also specialize in the preparation and review of regulatory submissions. We help you ensure the quality, consistency and technical validity of your CMC documentation during all phases of development, to approval and post-approval.
Our expertise includes small molecules, biologics and medical devices as well as products in all major dosage forms.
Regulatory documentation preparation, review and maintenance
- CMC documentation (Common Technical Document [CTD] module 3) for drug substances and drug products
- Product development reports
- Protocols, such as method validation, process validation and comparability
- Drug Master Files (DMFs) for the United States, Canada, Europe and other regions, including serving as US Agent
- Analytical method development and validation (including vendor selection, qualification and oversight)
- Formulation and process development, manufacturing and process validation (including vendor selection, qualification and oversight)
- Management of clinical trial material production
- Development of global regulatory strategies
- Design and management of active pharmaceutical ingredient (API) and drug product (finished formulation) development plans
- Quality assurance guidance relating to pre- and post-approval CMC changes
- Guidance on FDA and global regulatory requirements, regulations and guidances
- Development of quality assurance programs, including quality systems and standard operations procedures (SOPs)
- Post-approval support (such as annual reports and prior approval supplements)
- Due diligence reviews of development programs, marketing applications and manufacturing sites
- Management of registered information for global products
US Agent services
Our experts actively maintain regulatory documents, including Drug Master Files. We act as the representative for our clients, serving as the regulatory point-of-contact for the FDA and providing assistance in communications with FDA. This includes responding to questions from the FDA and scheduling inspections.