Description

To harness my knowledge and experience, and apply my skills in a practical manner to achieve significant improvements in how product development is conducted in the companies which I will help. The result is a firm focused on improving the success rate and speed of medical product development with a well-thought-through approach that meets the needs of investors as well as company management.

To improve the success rate and development speed of the clients biopharmaceutical and medical device discoveries. Working primarily with investor-driven emerging companies, I can help my clients make the critical decisions with respect to their product development investments, recognize and understand the scientific and regulatory issues that will impact their programs, avoid the common pitfalls that have derailed other companies and drug development programs, and design and implement optimal product development and regulatory programs.

Assurance of quality

ICH as well as European Commission, EMA and FDA directives and guidelines.

Services

• Strategic advice
• Select the optimal drug development programme
• Ensure that the company complies with relevant regulatory legislation in the countries within which they develop and anticipate marketing for their products. 
• Ensure regulatory intelligence to interpret regulations and describe regulatory requirements applicable for their business
• Communicate proactively with authorities to influence new regulations in accordance with company goals
• Interpretation of regulatory requirements, setting of standards and implementations
• Utilise staff and other resources effectively
• Create a dossier which does justice to your product
• Choose the right products to develop/licence-in
• Eliminate unnecessary delays in marketing new products
• Ensure that issues raised by regulatory agencies are resolved in an effective and timely manner
• Due diligence, including review of documentation, GMP, GLP, GCP
• Ensure an efficient scientific advice procedure by the authorities

• Clinical trial applications

Practical information

Please visit our website or contact us for more information. Malin Lundgren's CV can be downloaded below.

References: 

• www.indexpharmab.com 
• Accelerator AB 
• Catella Healthcare (Annika Espander) 
• Health Cap (Carl-Johan Dalsgaard)