Oral Solid Dose (OSD) Drug Development

Your discovery has the potential to make the world a healthier place, positively impacting the health of patients. Patheon, by Thermo Fisher Scientific, has the proven experience, scientific expertise and problem solving skills to make certain your molecule – small or large – lives up to its greatest potential. We will work with you to meet the requirements of every clinical phase faster, and more efficiently and cost effectively. And our proven track record of successfully moving from one development phase to the next helps to ensure that the therapies we make together have the best chance to reach the patients who need them most. Every step of the development process brings unique challenges and opportunities. Time, cost, and results are critical. But sacrificing quality is never an option. We have designed a range of flexible solutions to meet your molecule’s unique needs across formulation development, analytical method development, bioavailability enhancement, manufacturing process development and clinical batch manufacturing. As important, all our professionals – scientists, engineers, project managers and operators – are committed to a culture of problem solving. Bringing deep scientific insight, real-world development experience and always a “safe pair of hands” to your project. No one has touched more molecules than we have. With us, your molecule comes first. Whether your company is emerging or a giant in the industry, our people are dedicated to identifying the best path forward for your molecule. They are ready to guide you through our flexible, agile and scientifically driven development services from the very early stages of development through late stage trials and beyond.  

OSD Drug Development Expertise

Our Oral Solid Dose (OSD) development expertise includes:

  • cGMP manufacturing at all scales (Phase I, II and III)
  • Quick to Clinic™ options for first-in-human studies
  • A range of powders, granulates, tablet, capsule and softgel dosage options in a variety of formats to meet drug delivery needs
  • Advanced formulation options such as controlled release, abuse deterrent, bilayer and trilayer tablets, and multicomponent capsules
  • Various pediatric formulation options
  • Quality by Design (QbD) process development
  • Full analytical support and stability testing
  • Manufacture of blinded dosage forms such as over-encapsulation and matching placebos
  • Registration batches
  • CMC documentation for regulatory submissions
  • Confidence & reliability from our strong regulatory track record

 

OSD Drug Development Services

Learn about our OSD Dosage Forms.