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What We Do

Overview of FDA Expedited Development and Approval Programs for Serious Conditions

May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager |  Regulatory Affairs |  Drug Development Consulting

In May of 2014 and February of 2019, the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions.

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IMPACT’S Making an IMPACT Initiative Celebrates the Second Half of 2021

RESEARCH TRIANGLE PARK, NC: 01 March 2022 – In the second half of 2021, IMPACT’s employees continued their generous efforts via the Making an IMPACT (MAI) community service initiative. We continued our charitable and community outreach efforts by taking hybrid approaches to in-person and virtual service activities and celebrated our 6th annual Season of Giving campaign!
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Syner-G Acquires IMPACT, Expands Services for Biotech and Pharma Companies

Boston, MA (February 1, 2022) – Syner-G BioPharma Group (“Syner-G” or the “Company”), a leading provider of Chemistry, Manufacturing, and Controls (“CMC”) technical, regulatory, and compliance consulting services to pharmaceutical and biotechnology clients, today announced the acquisition of Impact Pharmaceutical Services (“IMPACT”). Based in Research Triangle Park, NC, IMPACT supports the outsourced medical writing, regulatory strategy, and regulatory publishing and submission needs of biotech and pharma companies from pre-IND through post-marketing of drugs and biologics.

Both Syner-G and IMPACT have demonstrated strong track records of consistent growth and success in providing customized and highly complementary solutions to support the development of quality of life enhancing and lifesaving therapeutics. The combination will allow the companies to provide an even greater depth and breadth of expertise while delivering the highest levels of scientific rigor and customer service.

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Jeff Golden Promoted to Senior Director, Regulatory Services

RESEARCH TRIANGLE PARK, NC: January 10, 2022 – In October 2021, Jeff Golden, was promoted to the position of Senior Director, Regulatory Services at Impact Pharmaceutical Services, Inc. (IMPACT).

Since joining IMPACT in 2016, Jeff has been a driving force in shaping the direction and growth of the Regulatory Services Department at IMPACT.  Jeff has also contributed significantly to the overall success of the company as a key member of Impact’s Leadership Team.  Under Jeff’s leadership, IMPACT’s Regulatory Services Department has more than doubled in size and provided regulatory publishing and electronic submission services to over 50 different biopharmaceutical companies in the United States and around the world.  In 2021, Jeff hired the company’s first Regulatory Affairs Managers, significantly expanding the regulatory service offering that IMPACT can provide to its clients.

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The Push for Patient-Focused Drug Development

January 10, 2022 | Julia DiFiore, PhD  |  Clinical Research Scientist I  |  Regulatory Affairs

Many of us involved with drug development derive a lot of satisfaction in knowing that our work contributes to improving the health of patients around the globe. We offer our insight and expertise to design studies, analyze the results, and hopefully one day submit everything to regulatory agencies so that patients can access the treatments they need.

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