Company Core Data Sheet (CCDS) Services at Masuu Global

Your Trusted Partner for Developing a New Company Core Data Sheet (CCDS) or Updating an Existing One

At Masuu Global, we specialize in the development and maintenance of Company Core Data Sheets (CCDS), ensuring they comply with the stringent standards set by global regulatory authorities. Our expert team ensures that every CCDS we create is meticulously authored, thoroughly reviewed, and properly approved, ensuring regulatory compliance and enhancing patient safety. By integrating advanced technology and industry best practices, we deliver efficient and accurate CCDS services, customized to meet the needs of pharmaceutical companies across diverse global markets.

Our Comprehensive CCDS Services:
  1. CCDS Development
We provide expert support in the development of new CCDS tailored to meet both local and global regulatory standards. Whether your drug is newly developed or entering a new market, our team ensures the CCDS meets all necessary criteria, with clear, concise, and compliant information for healthcare professionals and regulatory authorities.
  • Regulatory Alignment: Ensuring that your product’s data sheet complies with requirements from regulatory bodies such as the FDA, EMA, WHO, and others.
  • Detailed Documentation: Comprehensive and scientifically accurate information to support the drug’s safety profile, indications, dosage, and administration instructions.
  1. CCDS Updates

We understand that regulatory guidelines and scientific knowledge evolve over time. Masuu Global offers specialized services for updating existing CCDS to reflect New Safety Data, Regulatory Changes, Scientific Developments

 
  1. Regulatory Compliance
Ensuring that your CCDS complies with global regulatory standards is essential for maintaining product approval and market access. Our team ensures that your CCDS meets the requirements of:
  • FDA (U.S. Food and Drug Administration)
  • EMA (European Medicines Agency)
  • Health Canada
  • ICH E2E (International Council for Harmonisation)
  • WHO (World Health Organization)
  1. Patient Safety Focus
At Masuu Global, patient safety is at the heart of every CCDS we create or update. We focus on:
  • Clear Safety Information: Ensuring that all safety warnings, contraindications, adverse events, and precautionary details are clearly outlined and up-to-date.
  • Precise Dosage Information: Offering detailed instructions on drug dosage and administration to prevent misuse or overdose.
  • Updated Warnings: Reflecting the latest insights from clinical trials, real-world evidence, and pharmacovigilance activities.
  1. Authoring Services
Our team of expert medical writers offers comprehensive authoring services for the creation of detailed and compliant CCDS. Our services include:
  • Thorough Research: Comprehensive research on drug indications, safety profiles, and clinical trial data.
  • Structured Content: Clearly organized information, including drug composition, therapeutic uses, clinical pharmacology, and administration guidelines.
  • Regulatory Review: Ensuring that each section of the CCDS adheres to the necessary regulatory language and requirements.
  1. Global Market Standards
With Masuu Global, your CCDS is always tailored to meet the specific regulatory requirements of the markets in which your drug is sold. We ensure:
  • Global Harmonization: Aligning the content with regulatory requirements for markets such as Europe, North America, Asia, and others.
  • Region-Specific Requirements: Adjusting the CCDS based on the nuances of regional regulations, including specific safety or pharmacovigilance data required by local authorities.
  1. Expert Consultation
In addition to our CCDS development and updating services, Masuu Global offers expert consultation on:
  • Regulatory Guidelines: Assistance in navigating complex and changing global regulatory frameworks.
  • CCDS Best Practices: Advising on industry best practices for the creation and maintenance of CCDS.
  • Labeling Strategy: Helping you align your product’s CCDS with your overall labeling and marketing strategy.
  1. Technology Integration
We leverage advanced technology to streamline the development and update of CCDS. This allows us to:
  • Increase Efficiency: Our technology-driven processes allow for quicker turnaround times in the development and update of CCDS.
  • Ensure Accuracy: We use cutting-edge systems for ensuring the accuracy of drug data and preventing any regulatory discrepancies.
  • Automated Tracking: Automated systems for tracking regulatory changes and ensuring your CCDS is always up to date with the latest global standards.
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