Dossiers

Zach is dedicated to the worldwide development and registration of pharmaceutical generic drugs either using APIs from its internal pipeline or from selected API suppliers, exploiting its pharmaceutical expertise and, where possible, its corporate FP manufacturing sites. Focus is on high quality and strong control of the entire dossier development process from a regulatory standpoint.

Our portfolio includes several ophthalmics, niche and difficult to formulate products either injectables or solid oral dosage forms.

Our services include (but are not limited to):

• MA licencing
• Dossier licencing (for customers to be MAH)
• Technical information included in our dossier
• Dossier development consultancy