Dr Donal Coveney- Managing Director, TopChem Pharmaceuticals Limited

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    • Dr Donal Coveney- Managing Director, TopChem Pharmaceuticals Limited's presentations

    Presentation Title:

    Jumping through hoops and chasing our tails – challenges in securing market approval of generic pharmaceutical products.

    Presentation Synopsis:

    TopChem Pharmaceuticals develops generic pharmaceutical products mainly for the US market. While these products are known entities, we develop our own proprietary manufacturing processes, delivering high quality pharmaceutical grade active ingredients. Even though most of these products have been on the market for many years, as a new entrant we are quite rightly judged by the highest modern standards. This talk will focus on some case studies, which highlight the challenges encountered in securing market approval for our products.

    Speaker Bio:

    Donal has over 20 years experience in the pharmaceutical manufacturing sector in Ireland. He established TopChem Pharmaceuticals Limited in 2007 and has guided the company through US FDA and EU regulatory inspections leading to market approval of a range of niche pharmaceutical products.

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