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Case Study 5 – Regulatory Affairs Strategy and Project Team Lead

Impact Pharmaceutical Services

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 growth over the years has made “in-sourcing” of help a necessity.

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Top 20 Radiopharma Companies Based on Market Cap

PharmaShots

The company expects to commence P-I clinical trials on metastatic and pediatric primary bone cancer patients. FAP-2286 (labeled with lutetium-177), a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP), is the company’s lead asset amongst radiopharma products.

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Japan’s M&A Boom

Pharmaceutical Technology

“The business integration from 2005 to 2007 of the two separate companies to form the joint Daiichi Sankyo created one of Japan’s biggest pharmaceutical companies.” Like in many other sectors, China and India are the ones labelled as those which will lead the expansion.

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Is Drug Side Effect Information Trustworthy?

The People's Pharmacy

And here is a description of “ABOUT DAILYMED”: “The National Library of Medicine (NLM)’s DailyMed searchable database provides the most recent labeling submitted to the Food and Drug Administration (FDA) by companies and currently in use (i.e., “in use” labeling).” How Do Drug Companies Ask Questions?

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Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2003-2022)

PharmaShots

model is a holistic approach to incorporate the same strategy to life science and pharmaceutical companies. A globally fast-growing, and largest pharmaceutical company in the world was created through a merger between Pfizer and Pharmacia. Model: Inspired by the industry 4.0 model, the pharma 4.0

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Tracking the Drug Trail

Pharmaceutical Technology

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up.