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
- Placebo Manufacturing and/or Over-encapsulation of Comparator Products for blinded clinical trials
- 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