The Importance of Clear and Compelling Regulatory Preparation.

At PLG, we know how important is to prepare and submit all investigational and marketing applications correctly. We understand the role of effective planning, data compilation, regulatory strategy development, and continuous communication for successful regulatory submission. Our team is dedicated to guiding clients through these steps with a project management team to ensure that all projects are clear, precise, and consistent. Our expertise extends to a wide range of regulatory services, including:

  • CMC sections (Quality modules 2 and 3)
  • Clinical Trial (IND/IMPD/CTA)
  • Marketing Authorization (BLA, NDA/ANDA, MAA) application processes
  • DMFs, CEPS & ASMFs
  • Amendments and supplements
  • All pre- and post-approval license maintenance activities

Our Expertise and Global Impact

  • We take pride in our globally located expert teams and project managers, ensuring efficient and organized project execution.
  • We have a comprehensive understanding of regional requirements and possess detailed expertise in submission management for optimal results.
  • We excel in navigating the complexities of diverse regulatory frameworks and maintaining direct relationships with Health Authorities across multiple countries.
  • Strategically located worldwide, we help you prepare and submit requests to the FDA and EMA.
Due to the proactive project management, a dedicated team and adequate project planning, submissions are done sooner.

Multinational client for a Biotech MA project

Multinational client for a Biotech MA project