From Formulation to Market-Ready Drug Product Solutions

Formulation strategy development plays a pivotal role in the creation of new drugs and therapies. We excel in tackling challenges across lab-scale, scale-up, and production phases. Leveraging our extensive expertise in various manufacturing processes, we guide you toward an efficient drug product program. Our global proficiency extends to diverse pharmaceutical forms, encompassing small molecules, biologics, antibodies, as well as advanced molecules like pDNA, mRNA, gene, and cell therapies. We prioritize strict regulatory compliance, adhere to GMP standards, and offer quality control, clinical supply management, and due diligence assessments. Our unwavering dedication to precision and innovation empowers us to expertly navigate the complexities of drug product development, ensuring the confident acceleration of your pharmaceutical projects.

Our Commitment to Guiding Your Drug Product Journey

  • Our excellence is driven by a multidisciplinary team of professionals in the development, manufacturing, control, and regulatory affairs of your drug product.
  • We bring a broad range of expertise in regulatory and compliance strategies for all development phases and dosage forms.
  • We offer “person in plant” services to monitor critical experiments or manufacturing operations.
  • We provide on-site experts to oversee vital experiments or manufacturing processes, ensuring close monitoring and supervision.
  • From start to finish, we are committed to helping you achieve cost and time savings throughout every project.
I personally want to thank the DSI team for authoring an excellent CMC submission, answering numerous questions, & always being available to help. DSI did a great job with strategy & authoring, & the project never would have come together without DSI’s project manager’s leadership to completion. I will call on DSI again for the next one. Thank you, all!

Global Pharmaceutical company

Global Pharmaceutical company