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Patheon Overview Brochure

IND/IMPD Dossier Support

Patheon's early development customers can benefit from our years of experience working with regulatory agencies in the U.S. and around the world. We can provide you with extensive documentation prepared in the format required for the Chemistry, Manufacturing & Controls (CMC) section of your regulatory submissions. After hundreds of projects and filings we know exactly what it takes to eliminate any unnecessary delays.

Early development IND/IMPD dossier support at Patheon

  • Investigational New Drug (IND) for the US
  • Investigational Medical Product Dossier (IMPD) for EU

The key to a delay-free submission is completeness and accuracy. As the source of the data, Patheon will be more familiar with it than any third party vendor. And because of our seamless integration, the flow of that data will be fast and efficient. What's more, we will assist you in discussions with regulatory agencies, and quickly address any questions they might have.

Patheon's IND/IMPD dossier support is a perfect example of the strength of our experience and fully integrated approach to early development. It's part of what makes Patheon the fastest way to go from molecule to market.

Ask The Experts

Robert A. Lipper, Ph.D.

Robert A. Lipper, Ph.D.
Having ushered multiple products to market though the entire development process, Dr. Lipper is an e
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K. George Mooney, Ph.D.

K. George Mooney, Ph.D.
Dr. Mooney has 35 years’ experience in pharmaceutical sciences and exploratory drug development. He
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Mark A. Staples, Ph.D.

Mark A. Staples, Ph.D.
Having worked 32 years with all early to mid-stage companies, Dr. Staples is an expert at the early
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Rodney Pearlman, PhD.

Rodney Pearlman, PhD.
An expert in the development of scientific and business strategies for start-ups, Dr. Pearlman bring
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Leah Appel, Ph.D.

Leah Appel, Ph.D.
Dr. Appel has over 20 years’ experience in the pharmaceutical industry developing drug delivery tech
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William E. Weiser, Ph.D.

William E. Weiser, Ph.D.
Dr. Weiser is an expert in analytical method development and validation for APIs and drug products.
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