Regulatory Operations

Empower Your Product Journey with X Pharma Plus Regulatory Operations

Unlock limitless growth opportunities with X Pharma Plus. Our Regulatory Operations team delivers end-to-end solutions covering submission planning, artwork creation, and labeling compliance. We harness advanced technologies to streamline complex processes, ensure full regulatory adherence, and drive operational efficiency—minimizing risks and achieving our ultimate goal of zero recalls. Together, we help your products meet the highest global standards of quality and compliance.

 Regulatory Operations – Overview

X Pharma Plus excels in Regulatory Operations, offering a comprehensive range of services in pharmaceutical artwork, labeling, publishing, and submissions. As a premier provider, we deliver Regulatory-compliant artwork solutions for pharmaceuticals, medical devices, and related products, ensuring high-quality designs with zero recalls.

Our end-to-end drug labeling services address both global and regional requirements, leveraging AI technology to enhance accuracy and efficiency. With a dedicated global publishing team, we lead in submission processes, supporting clients with seamless and timely submissions.

X Pharma Plus ensures precision, compliance, and operational efficiency across all aspects of Regulatory Operations, making us the trusted partner for pharmaceutical and medical device companies worldwide.

 Regulatory Operations Services

“Provides end-to-end Regulatory Operations solutions, ensuring efficient submission planning, precise artwork creation, and full labeling compliance for zero recalls.”

  • Comprehensive Regulatory Expertise: Seamless submission support led by a dedicated team including Publishing Manager, Lead Publisher, Senior Publishing Specialist, and Document Specialist.
  • Tailored Support Options: Flexible team allocation to meet specific project requirements.
  • Detailed Literature Review: Conduct thorough literature searches to substantiate labeling content.
  • Label Content Change Control Management: Ensure compliance and accuracy for all updates.
  • World-Class Artwork Design Studio: Deliver high-quality, Regulatory-compliant artwork.
  • One-Stop-Shop Solution: End-to-end support for artwork creation and management.
  • Major Applications Management: Expertise in handling NDA, BLA, IND, DMF, NDS, ANDS, MAA, CTA, and Lifecycle Maintenance Submissions.
  • eCTD 4.0 Support: Comprehensive submission assistance tailored to eCTD 4.0, ensuring seamless compliance with evolving regulatory standards.
  • Global Labeling Knowledge: In-depth and updated understanding of labeling requirements from multiple Health Authorities, including US FDA, EMA, TGA, etc.
  • Highly Qualified Medical Writers: Experienced professionals with extensive Regulatory labeling expertise.
  • Right First Time (RFT) Approach: Minimize errors and ensure efficient submissions.
  • 24/7 Artwork Pack Management: Continuous operations for timely delivery and management.

Regulatory Publishing and Submissions

Delivers seamless Regulatory Publishing and Submission solutions, ensuring accuracy, compliance, and timely delivery across global health authority requirements.

  • Provide comprehensive administrative and submission support to ensure full compliance with regulatory requirements.
  • Manage submission planning, document compilation, publishing, and tracking across global markets.

Regulatory Labeling Services

Provides end-to-end Regulatory Labeling Services ensuring accuracy, compliance, and consistency across global markets.

  • Deliver streamlined labeling solutions tailored for global markets.
  • Ensure accuracy, compliance, and consistency of all labeling content in line with Health Authority guidelines.

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