Clinical Trial Material (CTM) Manufacturing

Clinical Trial Material (CTM) Manufacturing

We Offer:

  • Potent/cytotoxic and DEA scheduled API handling capabilities
  • Tablets (all types including controlled/sustained release tablets)
  • Capsules (Hard Gelatin), including liquid-in-capsules
  • Film Coating (including specialty coatings such as enteric and controlled release barrier¬†coatings)
  • Powder Blends and Over encapsulation
  • Wet and Dry Granulations
  • Liquid Oral Dosage Forms (including emulsions, suspensions and palatability enhancement/taste masking)
  • Ophthalmic and Otic preparations
  • Nasal Sprays/Gels
  • Topical Creams, Ointments and Gels
  • Development and Manufacturing of all types of Parenteral Dosage Forms including potent/cytotoxic compounds, sterile powders, suspensions, micro-emulsions.
  • Sterile Vials, Ampules, HDPE dropper bottles and Pre-filled Syringes
  • Aseptic fill and finish and Terminal Sterilization
  • Lyophilization cycle development and CTM manufacturing
  • Micro encapsulation and Depot implants
  • Sterile Powder Filling
  • Aerosol Delivery System
  • Analytical Methods Development
  • Stability Assessment (accelerated and long-term)
  • Regulatory Assistance
  • Packaging and Labeling of single and double-blinded clinical study kits including customized blister cards
  • CTM Storage and Distribution (Repository services)
  • Documentation Support for IND/CMC Development and Related FDA Submissions