Clinical Trial Supply Services
Guidance & Support
on the Path to Approval
The Tedor team is deeply committed to supporting your journey throughout each phase of clinical development. Given the criticality of avoiding clinical delays, we remain highly flexible when confronted with shifting timelines and have extensive experience storing and shipping investigational drug products. We also provide comprehensive support to help clients submit documents necessary for regulatory approval.
Tedor Clinical Trial Supply Services At-a-Glance
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Formulation & process development
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Clinical scale drug product manufacturing
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Placebo manufacturing
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Clinical packaging & kit design
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Comprehensive analytical services
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Regulatory submission support
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Clinical drug product logistics, inventory & project management
Investigational Drug Product & Placebo Manufacturing
Utilizing Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) approaches, we leverage our expertise and comprehensive manufacturing capabilities to safeguard the supply of investigational drug product (IDP) for every phase of your trial. Additionally, we utilize tailored tooling and manufacturing approaches to match the product dimensions, appearance, and relevant characteristics of your product.
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Tablets & capsules
– Single & multi-layer tableting
– Immediate release
– Modified-release tablets & capsules
– Extended-release tablets & capsules
– DEA schedules II-V controlled substances
– High-potency products
– Poorly soluble or highly variable APls
– Multi-API products
– Pelletized products
– Sustained &z or delayed release coatings
– Pellets in a capsule or pellets compressed within a tablet
– Abuse deterrent products
– Dry large molecule products - Encapsulation for powders, beads, granules, tablets, and combination drugs
- Powder biologics
- Orphan drug small-batch manufacturing
Clinical Product Formulation & Process Development Services
Our phase-appropriate rapid formulation and manufacturing optimization services reduce time to clinic, ultimately accelerating your path to market. Tedor’s expert team then works with you to optimize formulations and manufacturing processes as development advances to later-phase trials.
- Comprehensive formulation & process development services
- Fully-equipped pilot lab
- Phase II-IV formulation and process development optimization
- Scale-up and site transfer
Clinical Trial Supply Packaging & Labeling
Tedor collaborates with your team to design your clinical primary and secondary packaging and labeling program with compliance, speed to market, and patient and physician experience at the forefront.
- Comprehensive primary & secondary packaging expertise
- Primary & secondary labeling design
- Kit design
- Schedule I through V controlled substance packaging & label design
- Cold chain packaging design
- Design & production of patient leaflets and IFUs (instructions for use)
- Placebo & IDP blinding
- Randomization services
- Just-in-time labeling
Clinical Trial Supply Project Management
Our project management services manage the orchestration of all the elements required to ensure that the development, manufacturing, and distribution of your finished dosage form IDP is carried out efficiently, on budget, and on schedule.
- On-time completion of IDP development, manufacturing & packaging
- IDP warehousing & clinical site distribution management
- Creating, monitoring, and refining your clinical supplies plan
- IDP inventory management
Quality, Regulatory & Compliance Support
Our quality, regulatory, and compliance teams make sure your IDP and other clinical materials meet the necessary quality standards and comply with all appropriate regulatory requirements.
- Turnkey analytical services support process development & regulatory filings
- Regulatory filing support