Due Diligence
Biotechnology companies continue to drive innovation through pharmaceutical research and development. The continued growth of the pharmaceutical industry is, in part, supported by partnerships, mergers and acquisitions where portfolios of assets are continually acquired or divested. Both, organisations and investors need to understand the value and risks of assets from a developmental and regulatory perspective.
Our expertise in both, the regulatory environment and decision-making combined with our clinical insights enables us to evaluate independently the value and the key issues and risks of a product and/or a portfolio.
We will provide you with the probability of success of products in development to be acquired or divested based on a comprehensive state of art assessment.
We generate independent and high-quality due diligence reports thus providing a confidential, unbiased perspective.
Your decision-making and negotiation processes will benefit from our expertise in GCP and our broad experience in regulatory decision-making.
Company Information
ConEckt Consulting, founded by Dr. med. Klaus Eckhardt, MDRA, provides expert services and advice to drug developers in academia, start-ups, global pharma and biotech industry as well as for patient organisations, investors and regulatory authorities in clinical drug development and regulatory affairs. Our focus, offering advice on evidence generation by connecting clinical insights and regulatory expertise.
Our Purpose
Expedite the provision of therapies to patients to address their unmet medical needs
Our Services
We provide independent expert services and advice in all phases of clinical drug development and regulatory affairs as well as in due diligences. We help you define innovative and robust development strategies to generate the evidence needed for your target population. We offer medical writing support when it comes to clinical documents for your marketing authorisation application.
We facilitate meetings with key stakeholders such as regulatory agencies, HTA agencies and payers support the preparation of necessary briefing packages containing a full development strategy.
Thus, we can support you throughout the entire clinical development of your projects taking care that you generate exactly the evidence that is required by key stakeholders, such as regulatory agencies, HTA, and payers.
Success of your Drug is Our Motivation – Better Treatments for Patients with Unmet Needs
* For further information see Klaus Eckhardt´s CV: Download it now!