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Catalyst Regulatory Services, LLC

Mark A. Ammann. Catalyst Regulatory Services, LLC provides a wide-range of services targeted to the needs of companies at all stages of development. In 2016, we provided support to 52 pharmaceutical and biotechnology companies. Our goal is to work collaboratively with these companies to develop innovative, customized, strategic programs that help our clients obtain and maintain the regulatory applications necessary to study investigational drugs and biologics, in pursuit of market approval.

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PERFECT PRIVACY, LLC

12808 Gra●●●●●●●●●kway West

Jack●●●●ille , FL, 32258

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Catalyst Regulatory Services, LLC | catalystreg.com Reviews
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Mark A. Ammann. Catalyst Regulatory Services, LLC provides a wide-range of services targeted to the needs of companies at all stages of development. In 2016, we provided support to 52 pharmaceutical and biotechnology companies. Our goal is to work collaboratively with these companies to develop innovative, customized, strategic programs that help our clients obtain and maintain the regulatory applications necessary to study investigational drugs and biologics, in pursuit of market approval.
<META>
KEYWORDS
1 about us
2 staff
3 team and consultants
4 leadership
5 james bammert
6 anita fereshetian
7 melanie mcbride
8 toni marie nearing
9 stephanie pachy
10 additional consultants
CONTENT
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about us,staff,team and consultants,leadership,james bammert,anita fereshetian,melanie mcbride,toni marie nearing,stephanie pachy,additional consultants,colin davis,suzanne davis,cynthia kirk,roberta krieger,deborah ladenheim,kevin phelan,partners,offered
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Catalyst Regulatory Services, LLC | catalystreg.com Reviews

https://catalystreg.com

Mark A. Ammann. Catalyst Regulatory Services, LLC provides a wide-range of services targeted to the needs of companies at all stages of development. In 2016, we provided support to 52 pharmaceutical and biotechnology companies. Our goal is to work collaboratively with these companies to develop innovative, customized, strategic programs that help our clients obtain and maintain the regulatory applications necessary to study investigational drugs and biologics, in pursuit of market approval.

INTERNAL PAGES

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1

[Consultant] – Catalyst Regulatory Services, LLC

http://catalystreg.com/consultant-staff-2/tracy-acker

Mark A. Ammann. Regulatory Advertising and Promotion Expert.

2

Stephanie Pachy – Catalyst Regulatory Services, LLC

http://catalystreg.com/gallery/stephanie-pachy

Mark A. Ammann. Manager, Regulatory Operations. Stephanie began her pharmaceutical regulatory career in 2001 with Pfizer as a Document Specialist within the Global Regulatory Group, primarily responsible for the formatting of pre-clinical documents and ensuring their submission readiness. Completing label review for all products. Stephanie has extensive experience with Microsoft Word and publishing tools ISIToolBox and Adobe Acrobat.

3

Deborah Ladenheim – Catalyst Regulatory Services, LLC

http://catalystreg.com/gallery/deborah-ladenheim

Mark A. Ammann. Deborah Ladenheim, Ph.D. Senior Consultant, Regulatory Strategy. Led numerous meetings with health authorities in both US and Europe including pre-pre IND, pre-IND, end-of-phase I, European scientific advice. Two successful orphan drug designation applications in the US. Responsible for regulatory strategies for novel therapeutic concepts (nanotechnology, stem cell therapy). Developed regulatory strategies and submissions for pediatric projects.

4

Colin Davis – Catalyst Regulatory Services, LLC

http://catalystreg.com/consultant-staff-2/colin-davis

Mark A. Ammann. After leaving Pfizer, Inc. in 2005, he gained additional experience in the generic pharmaceutical industry working as an associate director of regulatory affairs for Hospira, Inc. and The Perrigo Co. Colin holds a Bachelor of Science degree in Chemistry from Miami University.

5

Full Service – Catalyst Regulatory Services, LLC

http://catalystreg.com/case-studies/full-service

Mark A. Ammann. Catalyst provides a full range of Regulatory services to established and “emerging” pharmaceutical companies. These include Regulatory Strategy, Liaison and Operations/submissions. In each case, Catalyst provided a strategist with extensive experience with the product type (small molecule, biologic, cellular therapy) and the therapeutic area (CNS, Oncology, Inflammation, etc) to provide regulatory leadership. Small Company “A”. Location: US West Coast. Small Company “M”. US Authorized Age...

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