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Regulatory Professionals, Inc.

Regulatory Professionals, Inc. Providing Strategic and Tactical Regulatory Services. Tuesday, November 4, 2014. RPI Introduces CMC Services. RPI is pleased to introduce our experienced team of Chemistry, Manufacturing and Controls (CMC) experts. RPI can provide you with comprehensive technical, compliance and writing support services for all of your CMC requirements at all stages of drug and biopharmaceutical development. Read more about our CMC experts below:. Ramon Burns, Ph.D. Malcolm McKay, Ph.D.

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Regulatory Professionals, Inc. | regprofessional.blogspot.com Reviews

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Regulatory Professionals, Inc. Providing Strategic and Tactical Regulatory Services. Tuesday, November 4, 2014. RPI Introduces CMC Services. RPI is pleased to introduce our experienced team of Chemistry, Manufacturing and Controls (CMC) experts. RPI can provide you with comprehensive technical, compliance and writing support services for all of your CMC requirements at all stages of drug and biopharmaceutical development. Read more about our CMC experts below:. Ramon Burns, Ph.D. Malcolm McKay, Ph.D.

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Regulatory Professionals, Inc. | regprofessional.blogspot.com Reviews

https://regprofessional.blogspot.com

Regulatory Professionals, Inc. Providing Strategic and Tactical Regulatory Services. Tuesday, November 4, 2014. RPI Introduces CMC Services. RPI is pleased to introduce our experienced team of Chemistry, Manufacturing and Controls (CMC) experts. RPI can provide you with comprehensive technical, compliance and writing support services for all of your CMC requirements at all stages of drug and biopharmaceutical development. Read more about our CMC experts below:. Ramon Burns, Ph.D. Malcolm McKay, Ph.D.

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regprofessional.blogspot.com

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Regulatory Professionals, Inc.: August 2014

http://regprofessional.blogspot.com/2014_08_01_archive.html

Regulatory Professionals, Inc. Providing Strategic and Tactical Regulatory Services. Tuesday, August 12, 2014. FDA Final Rule and Draft Guidance on Orphan Drug Designation. Amending the 1992 Orphan Drug. Became effective on August 12, 2013. The main change from the proposed rule was to add the definition of “orphan subset”. In particular, “ Orphan subset of a non-rare disease or condition (‘orphan subset’). With the drug.”. Clarifying that a designated drug that is otherwise the same as a previously appr...

2

Regulatory Professionals, Inc.: RPI Presenting at VxP Pharma Seminar in November 2014

http://regprofessional.blogspot.com/2014/09/rpi-to-present-at-vxp-pharma-seminar-in.html

Regulatory Professionals, Inc. Providing Strategic and Tactical Regulatory Services. Wednesday, September 24, 2014. RPI Presenting at VxP Pharma Seminar in November 2014. Donna Kato of RPI and Barry Calvarese, Ph.D. are featured speakers on "Essential Steps to Successful IND Submissions" at the VxP Pharma Seminar: Strategies for Success in Virtual Drug Development. The upcoming seminars are scheduled for:. November 11th: San Diego, California. La Jolla Hilton Torrey Pines. On the VxP Pharma website.

3

Regulatory Professionals, Inc.: FDA Guidance on Providing Regulatory Submissions in Electronic Format — Receipt Dates

http://regprofessional.blogspot.com/2014/08/fda-guidance-on-providing-regulatory.html

Regulatory Professionals, Inc. Providing Strategic and Tactical Regulatory Services. Tuesday, August 12, 2014. FDA Guidance on Providing Regulatory Submissions in Electronic Format — Receipt Dates. FDA Guidance on Providing Regulatory Submissions in Electronic Format — Receipt Dates. In February 2014, the FDA issued a guidance. To assist sponsors, applicants, and others making regulatory submissions in electronic, paper, or hybrid format to the Center for Drug Evaluation and Research (CDER). A paper subm...

4

Regulatory Professionals, Inc.: FDA Draft Guidance on Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

http://regprofessional.blogspot.com/2014/11/fda-draft-guidance-on-providing.html

Regulatory Professionals, Inc. Providing Strategic and Tactical Regulatory Services. Monday, November 3, 2014. FDA Draft Guidance on Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. In July 2014, FDA issued a revised draft guidance. And formatted according to the eCTD specifications outlined in this guidance. These requirements apply to. FDA will exempt the following types of submissions:.

5

Regulatory Professionals, Inc.: FDA Final Rule and Draft Guidance on Orphan Drug Designation

http://regprofessional.blogspot.com/2014/08/fda-final-rule-and-draft-guidance-on.html

Regulatory Professionals, Inc. Providing Strategic and Tactical Regulatory Services. Tuesday, August 12, 2014. FDA Final Rule and Draft Guidance on Orphan Drug Designation. Amending the 1992 Orphan Drug. Became effective on August 12, 2013. The main change from the proposed rule was to add the definition of “orphan subset”. In particular, “ Orphan subset of a non-rare disease or condition (‘orphan subset’). With the drug.”. Clarifying that a designated drug that is otherwise the same as a previously appr...

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Regulatory Professionals, Inc.

Regulatory Professionals, Inc. Providing Strategic and Tactical Regulatory Services. Tuesday, November 4, 2014. RPI Introduces CMC Services. RPI is pleased to introduce our experienced team of Chemistry, Manufacturing and Controls (CMC) experts. RPI can provide you with comprehensive technical, compliance and writing support services for all of your CMC requirements at all stages of drug and biopharmaceutical development. Read more about our CMC experts below:. Ramon Burns, Ph.D. Malcolm McKay, Ph.D.

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