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Umen & Co. - Strategic Regulatory Consulting and Medical Writing for Pharma and Biotech

We are the experts. Umen and Co. provides strategic regulatory consulting. And medical writing services. To the pharmaceutical and biotech industries. Our core strength lies in combining these two capabilities to create documents that are objective, persuasive, and supportive of labeling. We assist clients in preparing various NDA/BLA documents and in projects ranging from pre-IND information packages to post-approval supplements. By David N. Schwartz, BS. Michael J. Umen, PhD. Mary Vanderhoof, MS.

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Umen & Co. - Strategic Regulatory Consulting and Medical Writing for Pharma and Biotech | umenandco.com Reviews

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We are the experts. Umen and Co. provides strategic regulatory consulting. And medical writing services. To the pharmaceutical and biotech industries. Our core strength lies in combining these two capabilities to create documents that are objective, persuasive, and supportive of labeling. We assist clients in preparing various NDA/BLA documents and in projects ranging from pre-IND information packages to post-approval supplements. By David N. Schwartz, BS. Michael J. Umen, PhD. Mary Vanderhoof, MS.

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Umen & Co. - Strategic Regulatory Consulting and Medical Writing for Pharma and Biotech | umenandco.com Reviews

https://umenandco.com

We are the experts. Umen and Co. provides strategic regulatory consulting. And medical writing services. To the pharmaceutical and biotech industries. Our core strength lies in combining these two capabilities to create documents that are objective, persuasive, and supportive of labeling. We assist clients in preparing various NDA/BLA documents and in projects ranging from pre-IND information packages to post-approval supplements. By David N. Schwartz, BS. Michael J. Umen, PhD. Mary Vanderhoof, MS.

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umenandco.com

1

Umen & Co. - Strategic Regulatory Consulting and Medical Writing for Pharma and Biotech

http://www.umenandco.com/services.htm

Resurrecting a Product from a Pivotal Study with Negative Results. Providing General Regulatory Strategy and Preparing for a Meeting with FDA. All logos the property of. Umen and Co. offers a full range of strategic regulatory consulting and medical writing services. Our core strength lies in combining these two capabilities to create documents that are objective, persuasive, and supportive of labeling. CTD and eCTD Preparation. IND, NDA, BLA, MAA Preparation and Strategy. Rx to OTC Switches.

2

Umen & Co. - Strategic Regulatory Consulting and Medical Writing for Pharma and Biotech

http://www.umenandco.com/aboutus.htm

According to FDA reviewers,. Unfamiliarity with FDA regulations and the drug application process. Is a key problem for inexperienced sponsors and results. In poor quality submissions. Involve complementing teams with. Experienced regulatory consultants.*. All logos the property of. Source: Independent Evaluation of FDAs First Cycle Review Performance. Retrospective Analysis Final Report - January 2006. And medical writing services. What Makes Umen and Co. Unique? We combine strategic regulatory affairs e...

3

Umen & Co. - Strategic Regulatory Consulting and Medical Writing for Pharma and Biotech

http://www.umenandco.com/michaelumen.htm

Michael J. Umen. All logos the property of. Prior to founding Umen and Co., Inc., Michael worked for two Johnson and Johnson companies. He received a Ph.D. in organic chemistry from M.I.T., studied immunology at Harvard Medical School, pharmacology at Philadelphia College of Pharmacy and Science, and business at the Wharton School. US Patent Nos. 5734883. Michael Umen and Co., Inc. 352 North Easton Road. Glenside, PA 19038. Info @ UmenAndCo.com.

4

Umen & Co. - Strategic Regulatory Consulting and Medical Writing for Pharma and Biotech

http://www.umenandco.com/whitepapers.htm

An NDA is the. Only Form of a Drug That Most Regulators. A Firm Should Look. At its NDA as. An Example of its. All logos the property of. Keywords: Integrated summary of effectiveness; Integrated summary of safety; Summary of clinical efficacy; Summary of clinical safety; Common Technical Document. Understanding the Differences and Effectively Transitioning Between the US Integrated Summaries of Effectiveness and Safety (ISE/ISS) and the CTD Summaries of Clinical Efficacy and Safety (SCE/SCS). Are my med...

5

Umen & Co. - Strategic Regulatory Consulting and Medical Writing for Pharma and Biotech

http://www.umenandco.com/whyumen.htm

Why Umen and Co. To help me with every submission Ive. They have an extraordinary. Track record in this business. Michael M. Kitt, M.D. Senior Vice President,. All logos the property of. Simply put, we are the experts when it comes to integrating the strategy and. The content in a drug application! Good Medical Writing Requires a Solid Regulatory Strategy. Umen and Co. Strives for Excellence. Team Dynamics Play a Critical Role. Our listening skills and sensitivity to all types of issues and personalities...

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Umen & Co. - Strategic Regulatory Consulting and Medical Writing for Pharma and Biotech

We are the experts. Umen and Co. provides strategic regulatory consulting. And medical writing services. To the pharmaceutical and biotech industries. Our core strength lies in combining these two capabilities to create documents that are objective, persuasive, and supportive of labeling. We assist clients in preparing various NDA/BLA documents and in projects ranging from pre-IND information packages to post-approval supplements. By David N. Schwartz, BS. Michael J. Umen, PhD. Mary Vanderhoof, MS.

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