Empowering Pharma Innovation with CMC and Quality Expertise

Empowering Pharma Innovation with CMC and Quality Expertise

Our CMC and Quality development services consistently ensure patients receive effective, safe, high-quality medicines. We aim to guide you through the entire drug development life cycle, offering comprehensive CMC plans and strategies. We are there every step of the way, from the inception of process and formulation development to supporting all clinical trial applications, streamlining manufacturing processes, optimizing drug formulations, and facilitating regulatory approvals. Our approach extends to providing you with top-tier Quality assurance and compliance solutions to develop and manage pharmaceutical products, saving you valuable time and resources while meeting strict quality standards. With our integrated services, we will lead you towards pharmaceutical success.

Expert CMC Guidance for Your Unique Journey

  • We offer a customized and data-driven strategy for each project, understanding every project’s needs.
  • We specialize in guiding the level of data needed at various drug development stages and in support with preparation of technical documentation (Module 3 and Quality Expert Summary for clinical trial applications (CTA) including IMPD & IND, NDAs/MAAs, and BLAs.
  • Our multicultural team has extensive experience in many international markets, providing valuable insights into the expectations of various regulatory agencies.
  • Our long and deep experience with midsized and start-up companies, as well as with multinational corporations, ensures we understand and align with your needs.
By turning to PLG’s focused and targeted CMC support, companies can realize the full potential of their projects without having to incur the costs of a larger department.

Brian Lihou

Product Development Business Executive, North America

Brian Lihou 2023