Comprehensive drug substance development solutions for pharmaceutical success

Our drug substance services offer a comprehensive suite of solutions to drive pharmaceutical success. From early-stage development to commercial production, we guide you through the complex landscape of drug substance development. Our expertise spans CMC strategy formulation, process optimization, analytical method development, and API regulatory compliance. With a track record of excellence, we ensure your drug substance development journey is efficient, compliant, and delivers high-quality results for your pharmaceutical innovations – ultimately leading to successful market entry and patient benefit. With decades of experience, we navigate with you with precision and expertise through the intricacies of drug substance development.

Your Path to Drug Substance Excellence

  • Our access to renowned industry experts worldwide with experience in mitigating risks and expediting development programs is unmatched.
  • Our experts continuously preserve a record of first-cycle FDA approvals, streamlining product approval and reducing development timelines.
  • We possess expertise in applying current ICH guidance while effectively interacting with agency CMC regulatory authorities.
  • Our proficiency in developing, optimizing, and validating analytical methods for assessing drug substance quality guarantees adherence to the highest quality standards.
  • We provide a CMC HealthChek™ program, expediting regulatory adherence and time-to-market for your project’s success.
  • We have an extensive international network of CMOs, ensuring efficient API development and seamless regulatory collaboration.
We understand drug development and are passionate in driving our client projects from lead discovery to first-in-human studies and regulatory approval.

Johannes Roebers

Product Development Business Executive

Johannes Roebers