CLINICAL SUPPLIES (CTM)

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

SCALE-UP

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

Ropack 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

Ropack 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 committed to be your trusted manufacturing and packaging partner. Outsource your pharmaceutical or nutraceutical products to us with confidence.

• A unique International Serialization Hub
• 400+ cGMP cold storage locations
• cGMP-compliant facilities totaling more than 241,000 sq. ft.
• Temperature- and humidity-controlled facilities
• Three level 9 security vaults with biometric access for controlled substances
• Controlled substance management
• Dedicated project manager