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Franka Jürgens

Senior Consultant Regulatory Affairs

Franka Jürgens

Regulatory affairs expert in global regulatory strategy and CMC lifecycle management, specialized in small molecules and human and veterinary pharmaceutical products. More than 19 years in the pharmaceutical industry, including more than 15 in regulatory affairs; experience with EMA, BfArM, FDA and other national agencies and as quality expert for CTD Module 2.3 (QOS) and Module 3.

Articles by Franka Jürgens

1 article

Beyond the CTD: What European Manufacturers Should Know Before an ANDA Submission in the US
Article

Beyond the CTD: What European Manufacturers Should Know Before an ANDA Submission in the US

For European manufacturers, the US market offers significant opportunities, but successful market entry requires more than transferring an existing European dossier into a US submission. Manufacturers should assess the regulatory pathway, reference product, patent landscape, bioequivalence strategy and US-specific CMC documentation requirements early.

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Image notice: The illustrative and header images were generated using AI and do not depict real people, places, or events. The portrait photographs show real people.

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