From scratch or work in progress: we help companies set up compliance management systems (CMS) to meet regulatory requirements. Compliance is inherently complex. We analyze and evaluate before we start out to make sure our suggestions are in line with your business objectives.
Documents have a life cycle. And we support you in document management from the creation of a policy to its update and finally, its retirement and archiving.
Transparency Disclosure Obligations
Transparency creates trust. In pharma, we back companies to comply with industry standards relating to all transfers of values to European healthcare professionals and healthcare organizations.
Compliance Training and Awareness
The first step to visibility is awareness. Often compliance departments lack thereof. We support you in marketing your compliance efforts and their added value internally, no matter if the management board or key employees.
Record Keeping and Documentation
Compliance is associated with heaps of documents. Rightly so! We back you in making sure your current document management system (DMS) is up to standard of if not, in finding a system that is a good fit for you. We do not shy away from challenges, no matter if changing from paper-based to digital solutions or migrating documents from one system to another.
Third Party Due Diligence
Due diligence manages corruption risks associated with engaging third parties. It is a investigation process and thorough background check. We help companies set-up their process to mitigate corruption risk, advise on finding cost-effective due diligence service providers, and how to handle red flags.
Whistleblowing and Raising Concerns
The term whistleblow stands for confidentially alerting an organization about suspicions of misconduct. We assist companies in setting up whistleblowing policies. So we set up the process of how to raise concerns and assist in evaluating different options of whistleblowing hotlines.
Monitoring and Auditing
The annual audit schedule is an integral commitment to compliance. We help companies improve their audit process and offer support in implementing corrective and preventive actions (CAPAs).