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Case Study 1 – Establishment of a Long-Term Medical Writing Partnership

by Frank Sorce | Aug 21, 2022 | Case Studies

Download a PDF of this case study.   Establishment of a Long-Term Medical Writing Partnership In 2009, IMPACT (now part of Syner-G BioPharma Group) was contracted by a mid-size global pharmaceutical company to prepare 2 Phase 3 clinical study reports (CSRs) for a...

Case Study 2 – The Journey Leading to an Approved NDA

by Frank Sorce | Aug 9, 2022 | Case Studies

Download a PDF of this case study.   The Journey Leading to an Approved NDA In 2010, following a referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a mid-size biopharmaceutical company to assist them with an upcoming NDA...

Case Study 3 – Expert Regulatory Affairs Services for a European-Based Client

by Frank Sorce | Aug 9, 2022 | Case Studies

Download a PDF of this case study.   Expert Regulatory Affairs Services for a European-Based Client In 2011, following referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a small development stage pharmaceutical company...

Case Study 4 – Successful US/EU Marketing Applications for Big Pharma

by Frank Sorce | Aug 9, 2022 | Case Studies

Download a PDF of this case study.   Successful US/EU Marketing Applications for Big Pharma As a result of repeat business, IMPACT (now part of Syner-G BioPharma Group) was contracted by a large, global pharmaceutical company to author the CSRs and accompanying...

Case Study 5 – Regulatory Affairs Strategy and Project Team Lead

by Frank Sorce | Aug 9, 2022 | Case Studies

Regulatory Affairs Strategy and Project Team Lead IMPACT (now part of Syner-G BioPharma Group) has been providing Regulatory Affairs support to a mid-size pharmaceutical company since 2009.  Even though this company has a Regulatory Affairs Department, their rapid...

Case Study 6 – Regulatory Operations Department Developed and Flourishing

by Frank Sorce | Aug 9, 2022 | Case Studies

Regulatory Operations Department Developed and Flourishing In 2013, the IMPACT (now part of Syner-G BioPharma Group) management team decided that the company needed to build a Regulatory Operations department to support their existing and future client base. The staff...
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