KPPT provides comprehensive cGMP clinical trial material manufacturing and packaging services for all dosage forms, including specialized capabilities for potent/cytotoxic compounds, DEA scheduled substances, and double-blinded clinical study kits.
Our CTM services are designed to support your IND and clinical development program with speed, quality, and full regulatory documentation. We understand the time-sensitive nature of clinical supply and have the agility to meet demanding timelines while maintaining stringent quality standards.
Solid Dosage Forms
- Tablets — all types including immediate, controlled, and sustained release
- Capsules (Hard Gelatin), including liquid-in-capsule formulations
- Placebo manufacturing and 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 granulation
Liquid & Semi-Solid Dosage Forms
- Liquid oral dosage forms including emulsions, suspensions, and solutions with palatability enhancement/taste masking
- Ophthalmic and otic preparations
- Nasal sprays and gels
- Topical creams, ointments, and gels
Parenteral Dosage Forms
- All types of parenteral dosage forms including potent/cytotoxic compounds
- Sterile powders, suspensions, and micro-emulsions
- Sterile vials, ampules, HDPE dropper bottles, and pre-filled syringes
- Aseptic fill and finish
- Terminal sterilization
- Lyophilization cycle development and CTM manufacturing
- Microencapsulation and depot implants
- Sterile powder filling
- Aerosol delivery systems
Specialized Capabilities
Potent & Cytotoxic Handling
Dedicated isolator technology for safe manufacturing of high-potency APIs and cytotoxic compounds with full DEA registration for Schedules I–V.
Double-Blind Study Kits
Complete packaging and labeling of single and double-blinded clinical study kits including customized blister cards and patient-level randomization support.
CTM Repository Services
Long-term CTM storage and worldwide distribution repository services with temperature-controlled warehousing and chain-of-custody documentation.
IND/CMC Documentation
Full documentation support for IND, CMC development, and related FDA submissions including batch records, specifications, and analytical method packages.
Supporting Services
- Analytical methods development
- Stability assessment (accelerated and long-term)
- Regulatory assistance for IND and CMC submissions
- Packaging and labeling of clinical study kits
- CTM storage and worldwide distribution (repository services)
End-to-End Clinical Supply Chain Partner
KPPT can serve as your single-source clinical supply partner — from formulation development and manufacturing through packaging, labeling, storage, and global distribution. This integrated model eliminates handoffs, reduces timelines, and ensures consistent quality throughout your clinical program.
Why Choose KPPT for CTM?
Speed to Clinic
Our experienced team and modern equipment deliver the fastest turnaround in the industry — critical for time-sensitive IND filings and study initiation.
All Dosage Forms Under One Roof
From oral solids to sterile injectables to topicals — no outsourcing, no delays. Every step executed in-house under cGMP.
Regulatory Documentation Ready
Full CMC package preparation for IND submissions. KPPT's regulatory experience means your documentation is correct and complete.
Complete Confidentiality
All projects are executed under strict confidentiality agreements tailored to your IP and competitive needs.