TentaConsult Pharma & Med GmbH

TentaConsult is your consultant and service provider for healthcare products - we offer you full service for pharmaceuticals, medical devices, dietary supplements and cosmeceuticals in the field of regulatory affairs and quality management. TentaConsult - Consultancy for Life Science.

• Regulatory Affairs / Life Cycle Management medicinal products / medical devices
• Setting up QM systems for medical devices, medicinal products, cosmetics and food supplements
• (EU) Batch Release & Import medicinal products / Qualified Person AMG
• Legal Manufacturer & EC REP Medical Devices
• Clinical Evaluation / Biocompatibility Evaluation for medical devices
• Conducting and supporting complete conformity assessment procedures for medical devices and marketing authorizations for medicinal products
• Div. Assumption of responsibilities in accordance with the German Medicinal Products Act (including step-by-step plan / information officer / VP Wholesale)
• Pharmacovigilance of medicinal products / post-marketing surveillance of medical devices
• Differentiation issues for medicinal products / medical devices / cosmetics

• Strategic consulting
• Regulatory affairs
• Quality management
• Life cycle management