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Clinical Trial Manufacturing
(CTM) Know-How™

Our highly trained and expert regulatory affairs staff and scientists will accelerate your drug (NCE) or biologic (NBE) from preclinical testing through formulation development and clinical supply utilizing QbD principles.

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CLINICAL TRIAL MANUFACTURING (CTM) SERVICES

Concept to Clinic Know-How™

Pii provides insight and support of your clinical formulation development and clinical and commercial supply management — all while exceeding the FDA regulatory hurdles along the way. With proven expertise ranging across all sterile and oral dosage forms, Pii will lead you through the entire process accelerating your decision-making through every step of the way. Our team-based approach and seasoned project managers will ensure you have transparency and well-thought-out options at each step of the transition from product development to CTM to commercialization. Our campus in Hunt Valley, MD, seamlessly integrates R&D, regulatory affairs, manufacturing and analytical laboratories to deliver your product using Quality by Design (QbD) principles on time and accurately the first time.

QUALITY ASSURANCE THROUGHOUT YOUR PRODUCT LIFECYCLE

CTM Supplies (Phase I-III)

  • Preformulation studies
  • Formulation development
  • Clinical supply manufacturing and testing
  • Analytical method development and validation
  • Stability studies
  • Active pharmaceutical ingredient (API) and excipient release testing
  • Quality by Design (QbD)

Integrated Services

State-of-the-Art CTM Technologies

  • Technology Transfer
  • Process development
  • Process and Equipment Validation
  • Manufacturing for Clinical Supplies and Submission/Registration Batches
  • On Campus Analytical Testing
  • On Campus Stability Programs
  • Regulatory Affairs Advice and Support
    • Secondary Packaging
    • Quality by Design (QbD)

CTM Services with Experience-based Expertise

  • Process Capabilities
  • Aseptic Filling
  • Lyophilization
  • Spray drying
  • Blending
  • Sizing/Milling
  • High Shear Granulation (aqueous or organic solvents)
  • Fluid Bed Granulation (aqueous or organic solvents)
  • Roller Compaction
  • Tableting (monolayer and bilayer)
  • Encapsulation
  • Micro-dosing (API-in-capsule)
  • Capsule Banding
  • Extrusion/Spheronization
  • Tablet coating (aqueous and organic solvent)
  • Multi-particulate Coating (aqueous and organic solvent)
  • Solution Preparation
  • Vacuum Homogenization
  • DEA Controlled Substances (Schedule II – V)
  • Safebridge® OEB 1-4
  • Controlled Release (Sterile or Oral)
  • Solubility Enhancement
  • Organic Solvent Processing
  • Light Sensitive

Talk to a Pii Scientist