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CLINICAL SUPPLIES (CTM)

From Phases I - III, RPS satisfies your clinical supply requirements aligned with your key valuation milestones.

MEETING YOUR TIMELINES AND QUALITY EXPECTATIONS THROUGH A SEAMLESS SCALE-UP FROM FORMULATION TO MANUFACTURING, PACKAGING AND DISTRIBUTION OF YOUR CTM.

SCALE-UP

clinincal_supplies_man Independent of your trial size and CTM demands, Ropack Pharma Solutions is equipped to meet your needs. Using QbD principles at each phase of scale, RPS ensures that all supplies are manufactured at the highest degree of quality.

  • Fully scalable operations
  • Multiple solid oral drug dosage forms
    • Powders
    • Capsules
    • Tablets (single, bi-layer, tri-layer)
  • Technical data to support regulatory submissions
COMPARATOR BLINDING

comparator_blindingRopack Pharma Solutions develops clinical supply formulations to successfully blind the drug candidate without affecting its characteristics or performance, while maximizing patient compliance. In collaboration with our customer, we establish the most effective technique and study design.

  • Encapsulation
  • Over-encapsulation
  • Matching placebo
  • Randomization
CLINICAL SUPPLIES MANAGEMENT

clinical_supplies_managementRopack Pharma Solutions welcomes the challenge of solving complex supply issues by using a unique blend of traditional and innovative services that can significantly shorten timelines, reduce cost and improve drug availability and patient compliance.

  • Multi-disciplinary approach to clinical supply management
  • Agile response to mid-study changes
  • Efficient management of expiry date
  • IVRS electronic system for supply management
PACKAGING AND LABELING

 

  • Primary and secondary

THE ROPACK PHARMA SOLUTIONS ADVANTAGE

Ropack Pharma Solutions is driven by quality, scientific expertise and customer communication to ensure that your drug candidate is given the best path to market.

  • Scientists experienced with a combined approval of 22 commercial products
  • All scientists experienced in the big pharma industry
  • cGMP-compliant facilities totaling more than 340,000 sq-ft.
  • Ample cGMP cold storage
  • Licensed for controlled substance management
  • Dedicated project manager
  • Seamless drug development process from R&D to commercial manufacturing and packaging