With multiple flexible, production-ready suites, and our recently completed large-scale manufacturing expansion that included the addition of a dedicated suite for fluid bed drying, coating and granulation, TEDOR can support customer solid dose projects from clinical development through to commercial manufacturing. A special area of expertise, and experience, is our ability to handle products that are DEA schedule I-V for research though commercial production.
TEDOR’s QbD project management process represents a quality and customer-focused approach in solid dose product development and manufacturing. Our experienced and diverse specialists, combined with exacting scientific methodologies create a frictionless process, reducing risk and ensuring that customer timelines are achieved.
We know that meeting project timelines critical to your end goal and, in that regard, project management is the key to success. Our QbD milestone-based project management process that includes methodical assessment, analysis and planning from the very beginning, helps to ensure a successful outcome. Regular updates, including weekly, monthly or quarterly project team meetings as needed, are led by your single-point of contact to ensure efficient and accurate communication to your team at all stages of the project.
TEDOR’s efficient organizational structure allows for unparalleled responsiveness to our customers’ needs and empowers employees to initiate the appropriate action to keep your project moving forward to meet each milestone.
TEDOR’s long experience allows us to offer consulting for regulatory preparation and submission. Our acumen with FDA and DEA regulations has resulted in many first-submission approvals.
Inspected, and approved, by both the FDA and DEA, we’ve expanded our facility to accommodate a growing portfolio of solid dose products by adding capabilities and versatility to serve the more diverse needs for our customers.
Our CDMO-experienced leadership team and staff will work closely with your team right from the start to ensure we exceed performance expectations. Our highly specialized staff includes PhD’s, MBA’s, R.Ph’s, and commercialization experts. We are continually growing and evolving our staff through robust recruitment of top pharma and scientific talent both from here and abroad.
The majority of TEDOR customers sign on for additional projects even before finishing the first one. Their confidence in our people, our process and our way of working grows as they see that it’s heading toward a win. This is a resounding endorsement of our success in completing projects efficiently to achieve our customers’ product objectives. TEDOR is small enough to care and experienced enough to deliver.