Clemann Group
Consultancy and services integrator for pharmaceutical and medical device development. Provides EU legal representation for non‑EEA sponsors, GDPR representation and DPO support, regulatory and clinical development strategy, CMC/pharmaceutical affairs, IP and licensing support, procurement and quality advice. Target clients are innovative life‑science start‑ups, biotech and pharmaceutical sponsors seeking integrated development and regulatory support in the EU.
Industries
Nr. of Employees
small (1-50)
Clemann Group
Dijon, Bourgogne, France, Europe
Services
Act as legal representative for non‑EEA sponsors to enable clinical trial submissions and act as local agent in EU/EEA member states.
Provide GDPR local representation, shared or dedicated DPO resources, DPIA delivery and local‑language handling of data subject and authority requests.
Design clinical development plans, coordinate international clinical operations, and provide budget and project management support.
Regulatory positioning for medicines and medical devices and planning for CMC and galenic development integrated into development strategy.
IP value analysis, IP development strategy and support for licensing negotiations (in/out).
Setup of fundraising strategies and business development planning to align financing with development milestones.
Act as legal representative for non‑EEA sponsors to enable clinical trial submissions and act as local agent in EU/EEA member states.
Provide GDPR local representation, shared or dedicated DPO resources, DPIA delivery and local‑language handling of data subject and authority requests.
Design clinical development plans, coordinate international clinical operations, and provide budget and project management support.
Regulatory positioning for medicines and medical devices and planning for CMC and galenic development integrated into development strategy.
IP value analysis, IP development strategy and support for licensing negotiations (in/out).
Setup of fundraising strategies and business development planning to align financing with development milestones.
Expertise Areas
- Clinical trial management
- Regulatory compliance and EU representation
- GDPR and data protection representation
- CMC and pharmaceutical affairs
Key Technologies
- Clinical trial operations
- Regulatory submissions (EU directives)
- GDPR compliance and DPIA processes
- CMC development and galenic formulation
News & Updates
Recognition by French authorities for significant investment in research and development.
Agreement enabling tax credit support for research and experimental development activities.
Official registration to support partners in commercial acquisition of pharmaceutical products (national authority registration number referenced).
Recognition by French authorities for significant investment in research and development.
Agreement enabling tax credit support for research and experimental development activities.
Official registration to support partners in commercial acquisition of pharmaceutical products (national authority registration number referenced).