Clinical Trial Manufacturing

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


Equal Opportunity Employer

Pii provides insight and support of your clinical formulation development and clinical and commercial supply management — all while managing and staying ahead of 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 to accelerating your decision-making 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, process development and scale-up, manufacturing, analytical, and laboratories to deliver your product using Quality-by-Design (QbD) principles – on time and accurately the first time.


CTM Supplies (Phase I-III)

  • Preformulation studies
  • Formulation development
  • Clinical supply manufacturing and testing
  • Registration batches
  • Analytical and microbiology lab method development and validation
  • Stability studies
  • Active Pharmaceutical Ingredient (API) and excipient release testing
  • Quality-by-Design
Scientific Quality

Clinical Aseptic Vial Filling - M&O Perry


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 and microbiology lab testing
  • On-campus stability programs
  • CMC documentation support
    • Primary packaging and labeling
    • Secondary packaging and labeling
    • Quality-by-Design

CTM Services With Experienced-Based Results

  • Process capabilities (injectable vials, syringes, cartridges, oral and topical)
  • Aseptic filling
  • Terminal sterilization
  • Lyophilization
  • Spray drying
  • Blending
  • Particle sizing/milling
  • High/low shear granulation (aqueous or organic solvents)
  • Fluid bed granulation and coating (aqueous or organic solvents)
  • Roller compaction
  • Tableting (monolayer, bilayer, tab in tab, mini-tab)
  • Encapsulation (powders, pellets, granulations)
  • Liquid-filled hard capsules
  • Soft Gel capsules
  • Capsule banding
  • Extrusion/spheronization
  • Tablet coating (aqueous and organic solvent)
  • Multi-particulate coating (aqueous and organic solvent)
  • Solution/suspension preparation
  • Vacuum homogenization
  • DEA controlled substances (Schedule I – V)
  • Safebridge® OEB 1-4
  • Controlled release (Sterile or Oral)
  • Solubility enhancement
  • Organic solvent processing
  • Ability to handle light-sensitive and oxygen-sensitive Products

Talk to a Pii Scientist