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

Syner-G

AUGUST 9, 2022

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 submission documents to support a simultaneous US and EU submission for a combination respiratory product. and 2.7.2), and the Clinical Overview (Module 2.5).

Documentation 40
Documentation Clinical Pharmacology Pharmaceutical Companies Pharmaceutical Companies 40
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COVID-19 has propelled the regulatory industry years ahead

pharmaphorum

OCTOBER 18, 2021

Regulators and pharmaceutical companies are investigating cloud-based platforms to enable the real-time sharing of data. And advances in digitalisation could facilitate a move from document-based submissions to data-based submissions, through a cloud platform like the one being developed by Accumulus Synergy.

Vaccines 143
Vaccines Clinical Pharmacology Pharmaceutical Companies Pharmaceutical Companies 143
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