ADVANTAGES

Eight Essential Advantages of Tedor

Tedor is a small customer-focused oral solid dose CDMO with a strong track record of meeting aggressive development and commercialization timelines for small to mid-size pharma companies.  Over the past last 16 years we have helped our customers receive many product approvals, including 10 in the last 3 years. We attribute this success to our company-wide focus on quality, customer service and meeting timelines.  Everything we do, and how we do it, is focused on helping you to achieve your product objectives.  In short – we are small enough to care and experienced enough to deliver.

1

Flexibility

With 14 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 development through to commercial manufacturing.  A special area of expertise, and experience, is our ability to handle products that are DEA schedule II-V, which makes up a large part of our capacity.

2

Process

Built for speed and precision, 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.

KEY PHASES OF OUR PROCESS

  1. Assessment: Our vast experience in product development allows us to chart the best course for your product from the start of the project.
  2. Planning: Every project is unique and meticulous milestone-based planning is employed to anticipate, and avoid, possible pitfalls during the development or transfer process.
  3. Implementation: Once your path to success is optimally planned, our experienced project management team begins executing swiftly and accurately.  During this time, progress updates are communicated on a regular basis from your designated single point-of-contact and through project team, meetings and calls.
  4. Launch: When it’s time to launch, everything from quality control to integrated product development to manufacturing and packaging will have you on a path to commercial success.
3

Project management

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.

4

Responsive

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.

5

Compliance

Tedor’s long experience allows us to offer turnkey NDA and ANDA preparation and submission. Our acumen with FDA and DEA regulations has resulted in many first-submission approvals.

6

Facility

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.

7

Talent

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.

8

Retention

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.  Simply put – Tedor is small enough to care and experienced enough to deliver.

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