Welcome to X Pharma Plus

From strategy to submission, X Pharma Plus delivers global regulatory affairs services that streamline approvals and ensure your pharmaceutical products comply with international standards.

Global Regulatory Affairs Services – Overview

Pharmaceutical regulatory affairs services are critical for the successful registration of medicinal products with Health Authorities (HAs) worldwide. These services ensure compliance with evolving regulatory requirements, facilitating smooth and timely approvals.

The regulatory consulting team at X Pharma Plus possesses in-depth knowledge of submission requirements and stays current with global regulatory changes. Their expertise in pharmaceutical regulatory affairs is essential for managing submissions efficiently, minimizing the risk of rejection, and achieving timely approvals.

As a trusted partner in global regulatory affairs, X Pharma Plus provides end-to-end support for medicinal product sponsors. Our experts ensure that all documentation and information are thoroughly evaluated and submitted accurately, enabling successful product registration and global market access.

Regulatory Global Regulatory Affairs Services

“Comprehensive support for worldwide regulatory compliance and product approvals.”

  • Strategic regulatory submission roadmaps and reports for identified medicinal products
  • End-to-end regulatory affairs support throughout product development
  • Pre-submission technical meetings with US FDA, EMA, and other Health Authorities
  • Correspondence with global HAs for product registration and approvals
  • Guidance on finalizing product composition and designing submission specifications
  • Support in preparing protocols/reports for development, process validation, exhibit batches, hold-time studies, and stability studies
  • Local agent support for US and Canada
  • Oversight of pre-submission administrative activities
  • Technical gap analysis and guidance on additional/missing documents or data generation
  • Authoring and reviewing CMC modules for INDs, IMPDs, CTAs, NDAs (505b2), dossiers, and BLAs for innovator pharma, biologics, biosimilars, and vaccines
  • Authoring and reviewing CMC modules for ANDAs, ANDSs, MAAs, dossiers, and DMFs for generic products
  • Change-control evaluation and preparation of submission strategies
  • Preparation of CMC packages for post-approval changes (supplements, variations, amendments) and lifecycle management submissions (annual reports, renewals)
  • Handling Health Authority queries and preparing response packages
  • Comprehensive end-to-end pharmaceutical regulatory affairs services
  • Highly experienced pharma regulatory consultants
  • Full support for regulatory submission activities
  • Proven expertise in global pharmaceutical regulatory affairs

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