GCP-Inspections
Preparation of GCP-Inspections
Our services include:
Before approving a new drug, regulatory agencies are often conducting GCP inspections of clinical trials. The aim of those inspections is to ensure that clinical evidence, i.e., clinical data is credible and can support the approval of the drug.
Based on our experience with GCP inspections at BfArM and in the pharmaceutical industry we provide support in its preparation, conduct, and follow-up.
Peer Review and Medical/Scientific Writing of Clinical and Regulatory Documents
We review your data and generate high-quality documents that meet your exact requirements as well as those of the regulatory agencies and other stakeholders.
- Investigator Brochures (IB) and updates
- Clinical trial protocols
- Informed Consent Forms (ICFs)
- Clinical trial registry and database summaries
- Clinical trial authorisations/Investigational New Drug (IND) applications
- Investigational Medicinal Product Dossier (IMPD)
- Briefing documents for scientific advice
- Clinical study reports (Phases I to IV)
- CTD clinical summaries and overviews
- Summary of Product Characteristics
- Patient Information Leaflets
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!