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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's main radiopharma asset includes CycloSam (Samarium-153 DOTMP), a bone-targeting radiopharmaceutical developed by IsoTherapeutics. In Aug’21, the US FDA cleared QSam’s IND application for CycloSam. The company expects to commence P-I clinical trials on metastatic and pediatric primary bone cancer patients.

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Is Drug Side Effect Information Trustworthy?

The People's Pharmacy

The Origins of Most Drug Information: The source of virtually all drug information originates with the clinical trials conducted for FDA drug approval. The agency and the drug companies negotiate the final wording in the official prescribing information. How Do Drug Companies Ask Questions? Overlooking Adverse Drug Reactions!

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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. Its top 8 products contributed more than $1B to the company’s net revenue.

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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. The pilot scheme for this has been observed by the FDA and EU Commission.