Services for small and medium enterprises

Granzer Regulatory Consulting & Services provides modular service solutions designed to support your company in all aspects of your development program depending on your individual needs.

With the aim of promoting innovation of new medicines by SMEs, small and medium enterprises, the EU and US governments have implemented a set of special provisions acknowledging the fact that SMEs do not have the same resources as larger companies.

Since 2005 EMA’s “SME Office” facilitates communication with SMEs through dedicated personnel. SMEs can profit from substantial fee reductions for scientific advice and certain administrative services of EMA.

FDA's Small Business Assistance Program offers a unique opportunity for small companies to obtain confidential advice on compliance and to avoid situations that could delay product approval. The objectives are to provide general guidance for compliance requirements and to reduce the complexities faced by small businesses in dealing with a large bureaucratic organisation.

To find out whether your company qualifies for SME status, when and how you should apply and what the benefits are, contact us.

• Regulatory Strategy
• Regulatory Procedures
• Advanced Therapies
• Orphan Drug Development
• Paediatric Development
• Medical Devices
• Borderline Products
• Authority Meetings
• Electronic Submissions
• Market Access & Value Dossier
• Small & Medium Enterprises
• Medical Writing
• Project Management
• Due Diligence

• Business Development