About us
Coneckt Consulting

Our Expertise and Experience*

Dr. med. Klaus Eckhardt, MDRA, Founder and President of ConEckt Consulting, is certified pharmacist and medical doctor specialised in Clinical Pharmacology and holds a master’s degree in Drug Regulatory Affairs.

Over 25 years, Dr. Eckhardt gained in-depth expertise and broad experience in clinical drug development and regulatory affairs in multiple positions in academia (IKP, Stuttgart), at regulatory agencies (BfArM, EMA), pharma (Schwarz Pharma) and biotech (UCB Biosciences).

Since 2005, Dr. Eckhardt is lecturing in the Clinical Module in the renowned Master’s degree program in Drug Regulatory Affairs (MDRA) at the University of Bonn / German Society of Regulatory Affairs (DGRA).

Dr-Med-Klaus-Eckhardt

In academia

  • Implementation of Clinical Trial Directive 2001/20/EC (BfArM, Bonn)
  • Clinical Trial Authorisations (review and assessment of phase 1 -4 trials; BfArM, Bonn)
  • GCP Inspections (conduct and reporting at BfArM and EMA)

In regulatory agencies

  • Design, conduct, analysis and publication of pharmacokinetic/-genetic phase 1 trials (IKP, Stuttgart)

In Pharma and Biotech

  • Approval for Vimpat, Briviact (EU; both as tablet, solution for infusion, oral solution)
  • Multiple MAAs (Vimpat, Briviact, Xyrem, Lacosamide Pain) – Submission, Review (EMA)
  • Regulatory strategies for multiple products in early/late clinical development phases
  • Numerous agency meetings at EMA, FDA, and national agencies (BfArM, MHRA, MPA, AIFA)
  • Multiple Paediatric Investigational Plans (Vimpat, Briviact) - Submission, Review (EMA)
  • Orphan Drug Designation (Radiprodil, infantile spasms) - Planning of submission (EMA, FDA)
  • Design, conduct, analysis, and publication of multiple phase 1 to 4 clinical trials
  • Patient focused drug development (Design of Pilot Studies on Patient Preferences in multiple immunological indications such as Myasthenia gravis, Psoriasis)
  • Several due diligences in different indications (neurology, oncology)

He is author of more than 20 peer-reviewed publications.

For further information about Klaus Eckhardt view his CV: Download.

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!