Navigation Links
Tunnell Consulting Strengthens Regulatory Affairs Team with Addition of Industry Veteran Kati Abraham
Date:6/19/2017

Tunnell Consulting has been solving the most complex problems faced by life sciences companies for over 50 years. One of the biggest challenges faced by life sciences, biotech and pharmaceuticals companies today is in interpreting the complicated regulatory environment. Joining the firm’s regulatory affairs services team is Kati Abraham, who is well known in the industry and brings significant high-level expertise to the table to assist the firm’s clients in their regulatory journeys.

With more than 30 years of experience, Ms. Abraham has end-to-end regulatory experience ranging from pre-IND through BLA submission and lifecycle management, ushering new products into the pipeline, and developing compliance infrastructures for clinical sample testing laboratories.

“Every member of the industry is facing increased regulatory pressures, at every phase of their process,” said Maryann Gallivan, CEO at Tunnell Consulting. “Kati’s years of experience and deep understanding of the regulatory process has already proven an essential component in achieving regulatory success for our clients, and in getting their life sciences products to market faster.”

Ms. Abraham’s background includes experience in developing and managing cross-functional teams to develop, negotiate, and implement successful regulatory strategies for challenging products and to align them with real-world business goals. She has a solid background in direct interactions with the FDA and other regulatory bodies. Prior to joining Tunnell, she worked both in start-ups and in big biopharma, and held senior positions at Merck & Co. and GSK, as well as serving as Vice President, Regulatory Affairs at VaxInnate Corporation, where she was responsible for developing and executing regulatory strategy for products at all stages of development.

“Tunnell Consulting’s footprint in the biotech and pharma industries represents a perfect fit for me,” said Ms. Abraham. “I’m pleased to be able to join this group of experts as they help guide their clients through the minefields of regulation, overcoming barriers and gaining approval for new life-saving technologies.”

Tunnell Consulting’s regulatory services begin at the evaluation stage, running from drug discovery to market approval. In addition to supporting the full range of regulatory submissions and serving as liaison to regulatory authorities, Tunnell provides expert leadership to internal project teams and works with management to create specific and effective regulatory strategies.

About Tunnell Consulting
Founded in 1962 and serving many of the world’s leading life sciences firms and government agencies, Tunnell Consulting, Inc. integrates strategic, technical, process, and organizational skills to design and implement sustainable solutions that exactly meet client needs. With deep industry knowledge, extensive scientific credentials, and superior measurable results, we consistently boost the operating performance of each unique client we serve. To learn more, visit us online at http://www.tunnellconsulting.com.

Read the full story at http://www.prweb.com/releases/2017/06/prweb14437217.htm.


'/>"/>
Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved


Related biology technology :

1. Julia O’Neill of Tunnell Consulting Shares Process Validation Insights at Pharma Conference
2. Frédéric Lefebvre Joins Tunnell Consulting as Director Focused on Business Development in Europe
3. Dr. Walter Matzmorr Joins Tunnell Consulting
4. Gerard (Jerry) Guillorn Joins Tunnell Consulting As Group Vice President, Business Development
5. Julia O’Neill Joins Tunnell Consulting’s Operational and Process Improvement Practice
6. Tunnell Consulting Partners with Dr. Ajaz Hussain on Solutions for Life Sciences Product Development, Quality Assurance and Regulatory Compliance
7. Anthony A. Charity Joins Tunnell Consulting
8. Tunnell Consulting Names John S. Ross as Principal, Life Sciences
9. Boyd Technologies Selects The Copley Consulting Group to ImplementInfor’s CloudSuite Industrial (SyteLine)TM Solution
10. Trust Transparency Consulting Launches Ingredient Trade Association Incubator Program
11. Astrix Joins BIOVIA Consulting Partner Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... ... October 10, 2017 , ... Dr. Bob Harman, founder and CEO ... Diego Rotary Club. The event entitled “Stem Cells and Their Regenerative ... attendees. Dr. Harman, DVM, MPVM was joined by two human doctors: Peter B. ...
(Date:10/10/2017)... ... October 10, 2017 , ... The Pittcon Program ... honoring scientists who have made outstanding contributions to analytical chemistry and ... 2018, the world’s leading conference and exposition for laboratory science, which will be ...
(Date:10/9/2017)... ... October 09, 2017 , ... The Giving Tree ... products targeting the needs of consumers who are incorporating medical marijuana into their ... Phoenix, Arizona. , As operators of two successful Valley dispensaries, The Giving Tree’s ...
(Date:10/7/2017)... Oct. 6, 2017  The 2017 Nobel Prize ... scientists, Jacques Dubochet, Joachim Frank and ... cryo-electron microscopy (cryo-EM) have helped to ... structural biology community. The winners worked with systems ... routinely produce highly resolved, three-dimensional images of protein ...
Breaking Biology Technology:
(Date:4/11/2017)... , April 11, 2017 No two ... researchers at the New York University Tandon School ... Engineering have found that partial similarities between prints ... used in mobile phones and other electronic devices ... The vulnerability lies in the fact that ...
(Date:4/5/2017)... , April 4, 2017 KEY FINDINGS ... to expand at a CAGR of 25.76% during the ... is the primary factor for the growth of the ... https://www.reportbuyer.com/product/4807905/ MARKET INSIGHTS The global stem ... technology, application, and geography. The stem cell market of ...
(Date:3/30/2017)... 30, 2017 Trends, opportunities and forecast in ... by technology (fingerprint, AFIS, iris recognition, facial recognition, hand ... by end use industry (government and law enforcement, commercial ... banking, and others), and by region ( North ... Asia Pacific , and the Rest of ...
Breaking Biology News(10 mins):