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Regulatory Affairs

Diapharm advises pharmaceutical companies on regulatory affairs and assists them by providing technical excellence and creative ideas. We perform all tasks associated with ensuring marketability, managing and further developing products and complete product portfolios.

Regulatory advice and the analysis of current obligations, standards and available options are part of the service as is resolving matters of differentiation between, for example, cosmetics, medical devices and biocides. And – depending on the product class – assistance with national or international marketing authorization procedures (medicinal products) or registrations (traditional herbal medicinal products) and notification or certification processes (medical devices) is of course also one of the services provided. 

Regulatory affairs
regulatory advice
definition of marketability
paediatric medicinal products
marketing authorization
optimization of existing marketing authorizations
registration and evidence of traditional use
notifications of change
marketing authorization for medical devices
handling deficiencies and conditions
CTDs and eCTDs
Readability User Testings (read more)
environmental risk assessments

We undertake all work associated with obtaining marketing authorizations for chemically defined medicinal products as well as for herbals: Diapharm produces quality dossiers and pharmaco-toxicological and clinical expert reports. We format these documents as CTDs or eCTDs (electronic common technical documents). We provides competent regulatory advice and regulatory services on obtaining marketing authorization for medicinal products and will prepare the required environmental impact assessments or readability tests of patient information leaflets. For traditionally used herbal medicinal products our phyto experts produce evidence of traditional use and make applications for THMP registration in accordance with s. 39a-d of the German Drug Law (AMG).

After marketing authorization has been obtained, Diapharm manages the dossiers, for example making applications for extensions, and drafts notifications of change and/or variations in MRP procedures. We ensure that the products we manage are further developed and continuously optimized in line with the current market situation and statutory requirements. For example, we develop new dosages or dosage forms of medicinal products exclusively for children so that a Paediatric Use Marketing Authorization (PUMA) can be obtained.

In short: Diapharm provides a full and competent one-stop service for regulatory affairs.

 

	Strategic Advice
	Portofolio Management
	Regulatory Affairs
	Medical Affairs
	Clinical Management
	Pharmacovigilance
	Audits & Inspections
	Quality Services & Release
	Analytics