VH Regulatory Consulting

Regulatory strategy and planning
Preparation of key documents
Submission of dossiers


VH Regulatory Consulting GmbH & Co. KG offers a broad range of services in regulatory affairs.


Medicinal products


VH Regulatory Consulting GmbH & Co. KG has experience with all kinds of medicinal products – drug products with chemically synthesised active ingredients, biotechnology derived products, herbal medicines.


The services offered with regard to medicinal products include

• National procedures, EU Mutual Recognition procedures, EU decentralised procedures, EU centralised procedures
• Full and abridged applications
• CHMP referral procedures
• Clinical trial notifications/applications including compilation of IMPDs
• Regulatory strategy and planning
• Development strategies
• Scientific advice (national and CHMP scientific advice)
• Pre-submission meetings (national authorities and EMEA)
• Compilation of full dossiers or key documents (overviews, summaries etc.) in Common Technical Document format


VH Regulatory Consulting GmbH & Co. KG also offers regulatory services with regard to medical devices, cosmetic products and nutrition supplements.