CMC Regulatory Documentation Services

The ultimate success of your development project relies on a successful dossier submission. Covance understands this and provides you with comprehensive regulatory CMC dossiers and other regulatory documentation submission services through our Alnwick, UK site. Our team offers you scientists with an average of 27 years’ pharmaceutical experience and have the capabilities to write and compile comprehensive CMC regulatory packages for IND/CTA and NDA application.

By partnering with Covance, you benefit directly from our extensive knowledge of the global CMC regulatory environment and our years of experience in directly engaging with regulatory agencies. Our project management experience and high level of prior experience with our clients add tremendous value to your development program.

We offer you CMC regulatory documentation services as part of a full development service package or as a stand-alone service. Our extensive knowledge and experience also enables us to provide you with CMC regulatory strategy and consulting services.

From API, preformulation, formulation to dossier services, you can trust Covance expertise and benefit from our breadth of services.

Capabilities designed for your success include:

  • Preparation of CMC documents for inclusion in regulatory dossiers, including coordination, writing and compilation
    • Global marketing applications using the e-CTD format
    • Investigational Medicinal Product Dossiers (IMPD)
    • Investigational New Drug Applications (IND)
    • Quality Overall Summaries (QOS)
    • Clinical Investigator Brochures (CIBs)
    • Integrated drug development reports
    • Release testing monographs for APIs and drug products
    • Interaction with other disciplines such as toxicology and drug metabolism to ensure consistency of dossier sections
  • Review of technical CMC documents either authored in house or as a service to increase your probability of success with the regulatory agencies 
  • Consultation and response to questions from agencies                 
    • Responding to regulatory CMC questions from global health authorities    
    • Preparation of position papers and responses for potential regulatory questions
  • Production of IMPDs or INDs for the clinical administration of radiolabeled species
Service Profile
Covance provides you with comprehensive regulatory CMC dossier and other regulatory documentation submission services built on top-pharma expertise. Download a service profile to learn more.
Biomolecules

Develop, characterize, test and validate with Covance, no matter what technique or molecule you're pursuing. Our experience covers a wide range of biomolecules, including:

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