Services

Consultancy

  • for Pharmaceutical Industry
  • on the Field of Workplace Safety
  • on the Field on Medical Devices Development and Registration
  • for Registration of Novel Food and Food Contact Materials

 

Pharmaceutical Industry

  • Pre-clinical studies
    • Design and implementation of preclinical development plans,
    • Management and/or coordination of studies at contract facilities (EU, CH and US),
    • Data interpretation,
    • Completeness checks and reviewing of existing study reports
    • Preparation of regulatory submissions and interaction with regulatory agencies, due diligence of in-licensing candidates,
    • and de-risking strategies for preclinical issues
  • Preparation of pharmacological and toxicological expert-statements
  • Preparation of audits and monitoring of pre-clinical and clinical studies (GLP, GCP)
  • Scientific literature search
  • Preparation of documents for regulatory affairs: IB, IMPD, pre-clinical CTD Module: 2.4, 2.6 and 4
  • In-House lecture`s

Workplace Safety
(Services for the safe handling of active pharmaceutical ingredients)

  • Preparation of Risk (Safety) assessments and occupational exposure limits (OEL) for worker exposure, categorization and banding (OEB) based on scientific evidence
  • Determination of the permitted daily exposure (PDE) limit
  • Recommendations of appropriate control measures for risk management
  • In-House lecture`s

Medical devices development and registration

  • In-House Lecture: Medical device regulations (EU and US)
  • Strategic consulting
  • I advise you with the classification (also of your “borderline products”) and assist in compiling the technical and regulatory documentation.
  • Pre-clinical and clinical development: strategic study planning, coordination of the studies and the scientific evaluation of the results.
  • Completeness checks and reviewing of existing study reports
  • Preparing of assessments of the biocompatibility of your products as well as detailed toxicological expert reports.
  • My offer includes establishment of contacts and conduct negotiations with the notified bodies and competent authorities and strategic and regulatory advisory support with the labelling of medical devices.
     

Novel food and food contact materials

  • Food contact materials
    • Strategic consulting (EU/US)
    • Planning and management of migration and safety studies
    • Support for Submission
      • Planning of submission
      • Preparation of the technical dossier
      • Liaise with authorities (EFSA and FDA)
  • Novel food / Novel food ingredient / Food additives
    • Strategic consulting (EU/US)
    • Preparation of safety assessment reports