The maintenance of regulatory documentation often requires not only expertise but also judiciousness - and regulatory compliance takes up a large part of the time.
Current tasks are quickly postponed and documents then become non-compliant. We support you with implementation of changes and updates to adapt your regulatory documents to current version and standards.
Our life cycle management service include:
What distinguishes us: We combine operational expertise, regulatory intelligence and compliance awareness.
Our services include both the pre-approval and the post-marketing activities: from review, compilation and LoD check to an comprehensive update with focus on feasibility.
Regulatory compliance, multidisciplinary approach and updates where relevant.
For further information, please feel to contact us.
