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Latest From CROMA Pharma GmbH

Keeping Track: StrataGraft Continues US FDA’s Biologic Center Approvals Streak; Another CRL For Avenue’s Tramadol IV

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Complete Response Letters

How To Leverage Internal Regulatory Resources To Generate Income And Create Added Value For Clients

Croma Pharma is a drug and device manufacturing company in its own right, but the firm now offers regulatory consultancy services in the medical device and combination products area to small companies. What does it take?

Regulation Medical Device

Arkan Zwick Q&A, Part 1: Choosing An EU Notified Body For Drug/Device Combinations In A Rapidly Changing Environment

Selecting a notified body that has capacity, expertise and staying power is a challenge in itself. But when it comes to selecting a good one for drug/device combinations products, how should companies proceed? Croma Pharma executive Arkan Zwick offers his insight in this first part of a two-part Q&A. Check out the second part here.

Europe Regulation

Deals Shaping the Medical Industry (12/2009)

The dealmaking column is a survey of recent transactions, including strategic alliances, mergers & acquisitions, and financings, in the life sciences industries. Deals are listed by the following industry sectors: in vitro diagnostics, pharmaceuticals, medical devices, and research/analytical instrumentation and reagents. All transactions are excerpted from Elsevier's Strategic Transactions database, providing comprehensive transaction coverage from 1991 to the present.

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