How we can support you

At Granzer Regulatory Consulting & Services we assist you with a wide range of services that cover all the stages of development of your products to meet the requirements of regulatory as well as payor authorities. We are especially dedicated to support you with new ideas and in bringing forward innovative medical therapies. Through our close contact with regulatory bodies, we are able to anticipate and advise you on new developments in regulations. In addition, we can help you to integrate the additional needs of Health Technology Assessments and/or payor authorities that patients get access to your drugs with a fair and competitive price. We are committed to adapting our services to your special needs.

• Are you seeking support in conceiving your regulatory strategy and building a road-map to the market?
• Are you planning for meetings with regulatory and payor authorities?
• Are you aware of the requirements for the development of medicines for children or do you need help with paediatric development plans?
• Is your drug eligible for Orphan Drug status?
• Would you like to benefit from our experience in managing electronic submissions?
• Are you an SME and would like to benefit from the financial and administrative help provided by the European and US governments?
• Would you like to analyze your odds to meet the requirements for market access in Germany as well as its impact on other markets?

• 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