Patheon is a global provider of development and commercial manufacturing services for solid and sterile prescription drugs, offering a wide variety of services and products. SEE AND Read More »

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Regulatory Dossier Support

Patheon's late 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.

Late development regulatory dossier support at Patheon

  • New Drug Application (NDA) for U.S.
  • MAA for EU
  • 505 (j) - ANDA
  • 505 (b)(1)
  • 505 (b)(2)

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 represent you before regulatory agencies, and quickly address any questions they might have.

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

Ask The Experts

Ann Newman, Ph.D.

Ann Newman, Ph.D.
Dr. Newman’s expertise is in solid-state chemistry: physical forms, polymorphism, salts, cocrystals,
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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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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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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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