Pharmaceutical Development Group

Pharmaceutical Consultant and FDA Regulatory Strategist

Innovator or Generic, All Roads Lead to the 505(b)(2)

Pharmaceutical Development Group

Faced with decreasing R&D output, billions of dollars in patent expirations and increasing generic competition, innovators are forced to re-evaluate traditional business models.

At the same time, generic manufacturers face more competition than ever before.

The result has been pressure on pharmaceutical companies across the board to adapt their strategies and transform their organizations to maintain income, while developing new revenue streams.

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