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Company Core Data Sheet Management Services

ClinChoice helps biopharmaceutical companies prepare and manage global and local company core data sheets (CCDS), one of the most complex activities in regulatory operations.

Our team has proven experience in centrally managing the entire label lifecycle, from initial design and review to obsolescence.

Our services for regulated life sciences products include:

  • Development of the Investigational Brochure (core safety information), target product profiles, and target labeling
  • Authoring and design of effective, defensible labeling content and format implementation before filing
  • Assistance with regulatory requests to correct non-compliant proposed labeling content
  • Writing or updating labeling documents, including CCDSs
  • Creation of:
    • A labeling decision-making structure for products under development and post-marketing labeling changes
    • The structure and features of CCDSs and guidance in populating implementable CCDSs
    • Labeling project management systems to manage requests, document decisions, track implementation, and integrate product knowledge bases
    • Labeling databases and document management systems for tracking and auditing systems

 

Regulations for required product labeling vary widely from region to region. ClinChoice assists with designing and developing CCDSs containing all necessary information enabling local labeling for:

  • Approved indications
  • Dosing requirements
  • Methods of administration
  • Concerns of special patient populations
  • Packaging and storage requirements and limitations
  • Incompatibilities and pharmacological properties
  • Safety information

 

After the product launches, each CCDS must be updated to reflect the product’s evolution.

We can assist in updating the CCDS to show:

  • New indications
  • Changes in dosage and administration
  • Changes in handling procedures
  • Safety concerns

 

Our service streamlines change requests to local labeling documents and the CCDS. We specialize in identifying labeling prospects in an existing portfolio, and we can provide strategic CCDS consulting.

Our labeling service includes:

  • Comparative analysis of local label content
  • Preparation of a label comparison chart showing similarities and differences
  • Evaluation of similarities and differences for inclusion in a CCDS
  • Provision of guidance on additional CCDS elements required to meet regulatory requirements in all desired markets
  • Creation of a draft CCDS and updates