Compliance Management

Compliance with legal requirements is a constant challenge for companies and managers. Those who violate the rules can face consequences ranging from reputational loss through to serious sanctions. This places severe demands on the company’s management and consequently also on compliance and legal departments that support the company’s management in carrying out its tasks. Together with companies, Catus develops and implements effective compliance management systems (CMS) tailored to the specific needs.

  • Development of a risk-based compliance program
  • Conducting compliance risk analyses
  • Compliance ‘health checks’ (overall analysis and evaluation of a compliance program at a glance)
  • Acting as ombudsperson for companies
  • Evaluation of allegations (management of suspected incidents)
  • Consulting on companies on compliance, data protection or corporate criminal law issues
  • Consulting on current legislative and regulatory projects: German Corporate Liability Act (Verbandssanktionengesetz, VerSanG), Act on Corporate Due Diligence Obligations in Supply Chains (Lieferkettensorgfaltspflichtengesetzt, LkSG), EU Whistleblower Directive and German Whistleblower Protection Act (HinSchG), etc.
  • Project management in compliance and data protection
  • Compliance training
  • External Compliance Officer

  SERVICE DESCRIPTION

Healthcare Compliance

Pharmaceutical, medical device and life science companies are subject to particularly strict legal regulations and compliance requirements. Together with these companies, Catus develops and implements robust healthcare compliance programs in accordance with criminal and competition law requirements, also taking into account the codes of associations for self-regulation such as the association “Freiwillige Selbstkontrolle für die Arzneimittelindustrie e. V. ” (FSA, Voluntary self-regulation for the pharmaceutical industry), the association “Arzneimittel und Kooperation im Gesundheitswesen” (AKG, Pharmaceuticals and collaboration in the healthcare sector) or the Bundesverband Medizintechnologie e. V. (BVMed, German Medical Technology Association).

  • Consulting on the implementation of interactions between the pharmaceutical and medical device industry and healthcare professionals, healthcare organizations, and patient organizations (contract preparation, documentation requirements, etc.)
  • Development of internal compliance guidelines and standard processes for the pharmaceutical and medical device industry (for example, approval and documentation processes for interactions with healthcare professionals and patient organizations)
  • Healthcare compliance training courses
  • External Healthcare Compliance Officer

  SERVICE DESCRIPTION

Does your company have a Compliance Management System (CMS) that meets the growing requirements? Make a first ‘health check’ with the Catus Compliance Calculator. It will guide you through the most important elements of a robust CMS. The evaluation will give you an initial assessment on a possible need for action. The Compliance Calculator does not replace legal advice, but serves as an initial guide. Personal data will not be processed. Estimated time: 5 minutes.

 

Compliance Calculator

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