Accelerated Development

Faster, Proven Solutions for your Breakthrough Designation and Orphan Drugs

Accelerated regulatory pathways of fast track and breakthrough designations can often shave years off the approval process. Accelerating the development and approval of many drugs is often in everyone’s interest, especially when the drug in question is to treat a rare or life-threatening disease. We have integrated solutions from development to commercialization and in-house efficiencies to help ensure your project success. 

Development-and-Analytical-Services

Integrated Solutions

Fully integrated services from development, analytical, clinical supply and niche commercial manufacturing. 

Deep Expertise

A proven track record of orphan, break-through and fast-track and accelerated development projects

Faster to Market

Highly-efficient in-house services to accelerate the process from molecule to final drug product.

Integrated Solutions

  • Analytical development, validation, release and stability testing
  • Pre-formulation and Formulation development
  • Clinical Trial Packaging/labeling
  • Clinical Warehouse/distribution support
  • Scale-up, registration and process validation batch manufacture
  • Commercial manufacturing
Facilities
  • 14,000 sqft Experimental Pharmaceutics Laboratories
  • 38,600 sqft Analytical Laboratories
  • 27,000 sqft GMP Manufacturing Facility
  • 49,500 sqft Packaging and Logistics Facility
Personnel
  • Experienced Management team
  • Scientists and Operators with decades of experience
Deep Expertise
  • 20+ industry experiences in oral solid formulation development
  • Good track record with successful commercial launch of multiple drug products having expedited designations
  • Exceptional science and technical support with a passion to solve development challenges
  • A culture of team work and innovation with a passion for meeting client expectations
Faster to Market 
  • Catalent’s integrated services and advantages of Precision Dispense can help reduce development costs and reduce your timelines to clinic.
  • Advantages of Precision Dispense
    • Both Xcelodose and Autodose Precision Dispense Technologies
    • Allows for matching technology to API physical attributes
    • Multiple Xcelodose and Autodose units on-site
    • Support of larger Phase 2 studies
    • Reduced Timelines to Clinic
    • Excipient Compatibility Not Needed
    • Analytical Methods Simplified
    • Content Uniformity Testing Omitted
    • Lower Development Cost
    • Formulation Development Not Required
    • Complex Analytical Methods Not Required
    • Single development team from development through commercialization
  • Co-located site solution to reduce time to clinic and to market
  • Experienced Project Management Team critical to maximize team efficiency
  • Flexibility working with small to mid-size clients where speed and agility is critical
  • Successful commercial launch of multiple drug products having expedited designations